8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): August 11, 2009

Avanir Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-15803	33-0314804
(State or other jurisdiction of	(Commission File Number)	(I.R.S. Employer
incorporation)		Identification No.)
101 Enterprise, Suite 300, Aliso Viejo, California		92656
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (949) 389-6700

Not Applicable

Former name or former address, if changed since last report

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

TABLE OF CONTENTS

EX-99.1

EX-99.2

Item 8.01 Other Events.

     On August 11, 2009, Avanir Pharmaceuticals, Inc. (the “Company”) issued a press release (the “Press Release”) announcing that the investigational drug Zenvia (dextromethorphan/quinidine) met its primary efficacy endpoint in the treatment of pseudobulbar affect in the confirmatory Phase III STAR trial. The Press Release provided top-line clinical data regarding the safety and efficacy of 30/10 mg and 20/10 mg doses of Zenvia compared to placebo. A copy of the Press Release is filed herewith as Exhibit 99.1 and is incorporated herein by reference.

     Also on August 11, 2009, the Company hosted an investor conference call, which was open to the public, to discuss the Press Release and the results from the STAR trial. A copy of the presentation slides from this conference call is filed herewith as Exhibit 99.2 and is incorporated herein by reference.

Cautionary Note Regarding Forward Looking Statements

     Certain statements in this filing that are not historical facts, including the exhibits incorporated herein, may constitute “forward looking statements,” which are subject to numerous risks and uncertainties. These statements are characterized by words such as, “expect”, “believe”, “should”, “project,” “plan,” “anticipate” and “intend.” Actual results could vary significantly from the anticipated results expressed or implied by any forward-looking statements. For example, there can be no assurance that the FDA will approve Zenvia for any indication, that subsequent complete analyses of clinical data will be consistent with the preliminary “top line” data reported herein, or that the Company will meet projected clinical or regulatory timelines. Risks and uncertainties affecting the Company’s financial condition and operations also include the risks set forth in the Company’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Copies of these reports are available from the Company upon request. The Company disclaims any intent to update forward-looking statements.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press Release, dated August 11, 2009
99.2	Presentation slides from an investor conference call of August 11, 2009

* * *

2

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: August 11, 2009	Avanir Pharmaceuticals, Inc.
	By:	/s/ Christine G. Ocampo
		Christine G. Ocampo
		Vice President, Finance

3

Exhibit Index

Exhibit No.	Description
99.1	Press Release, dated August 11, 2009
99.2	Presentation slides from an investor conference call of August 11, 2009

4

EX-99.1

Exhibit 99.1

AVANIR ANNOUNCES POSITIVE PHASE III STUDY RESULTS FOR ZENVIA

* ZENVIA MET PRIMARY EFFICACY ENDPOINT IN CONFIRMATORY TRIAL *

*ZENVIA DEMONSTRATED IMPROVED SAFETY AND TOLERABILITY PROFILE*

ALISO VIEJO, Calif., August 11, 2009 — Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the investigational drug Zenvia™ (dextromethorphan/quinidine) met its primary efficacy endpoint in the treatment of pseudobulbar affect (PBA) in the confirmatory Phase III STAR trial. Both Zenvia 30/10 mg and 20/10 mg provided a statistically significant reduction in episode rates over the course of the study when compared to placebo (p<0.0001). In an additional analysis of the primary endpoint, at week twelve (end of study), patients in the Zenvia 30/10 mg group reported a statistically significant mean reduction of 88% from baseline in PBA episode rates (p=0.01). Also in this study, Zenvia was generally safe and well tolerated. Avanir management will conduct a conference call to discuss this announcement today at 5:00 AM PST (8:00 AM EST).

“Frequent, unpredictable and often intense emotional outbursts may take a devastating toll on patients with PBA and their loved ones. The results of the STAR trial indicate that the new low dose formulation of Zenvia can substantially reduce the number of PBA episodes that these patients experience,” said Jeffrey Cummings, MD, Augustus Rose Professor of Neurology at the David Geffen School of Medicine at UCLA and Steering Committee Chairman for the STAR trial. “With no FDA approved treatments currently available, there is a real unmet medical need for the estimated 2 million patients in the U.S. living with the burden of PBA.”

“The STAR data indicate that the new low dose Zenvia formulations offer an improved safety and tolerability profile while continuing to deliver statistically significant and clinically meaningful efficacy in the treatment of PBA,” said Keith Katkin, Avanir‘s President and CEO. “We are very encouraged by the top-line results and we believe that the STAR data should be sufficient to address the issues outlined in the FDA approvable letter. We hope to have a full presentation of the STAR trial results at a scientific meeting later this year and plan to submit our complete response to the FDA in the first half of 2010.”

EFFICACY RESULTS

The primary efficacy analysis was based on the changes from baseline in crying/laughing episode rates recorded in the patient diary. Episode counts were reported and analyzed as a rate expressed as episodes per day. The primary outcome was the additional reduction in episode rates experienced with Zenvia 30/10 mg compared to placebo. In the STAR trial, Zenvia 30/10 mg provided a 47.2% incremental reduction in episode rates compared to placebo over the course of the study (p<0.0001). In a secondary analysis of the primary endpoint, Zenvia 20/10 mg also provided a statistically significant incremental reduction of episode rates compared to placebo (p<0.0001).

An important secondary endpoint analysis was based on the change from baseline to end of study using the Center for Neurologic Studies Lability Scale (CNS-LS). The CNS-LS is a validated instrument measuring the frequency and severity of PBA. In this secondary endpoint analysis, patients receiving Zenvia 30/10 mg

reported a significantly greater reduction in mean CNS-LS score compared to patients who received placebo (p=0.0002).

Additional secondary endpoints were included to help expand the Company’s understanding of the potential clinical utility of Zenvia. These additional endpoints include: 1) SF-36 Health Survey, 2) Neuropsychiatric Inventory Questionnaire (NPI-Q), 3) Beck Depression Inventory (BDI-II), and 4) Pain Rating Scale score (MS patients only). Data from these secondary efficacy endpoints, as well as additional exploratory analyses, are expected to be reported at an upcoming scientific meeting later this year.

SAFETY AND TOLERABILITY RESULTS

Overall, Zenvia was generally safe and well tolerated in this study. In the STAR trial, 90.9%, 82.2% and 86.2% of patients completed the 12-week double blind phase of the study in the Zenvia 30/10 mg, Zenvia 20/10 mg and placebo groups, respectively. The most common reason for early withdrawals was due to adverse events (AEs). Early withdrawal due to AEs occurred in 3.7%, 7.8% and 1.9% for the Zenvia 30/10 mg, Zenvia 20/10 mg and placebo groups, respectively. The proportion of patients reporting at least one AE was 83.2% in the Zenvia 30/10 mg group, 80.4% in the Zenvia 20/10 mg group and 81.1% in the placebo group. Reported AEs were generally mild to moderate in nature. The most commonly reported adverse events that appeared to be more frequent than placebo were dizziness, nausea and diarrhea. While commonly reported, falls, headache, somnolence and fatigue were no different than placebo. The most commonly reported AEs (>5% of patients) in the Zenvia treatments groups are summarized in the table below.

Most Common Adverse Events (>5% of patients)

	Zenvia 30/10 mg			Zenvia 20/10 mg			Placebo
	N = 107			N = 102			N = 106
Falls		22 (20.6	)		14 (13.7	)		21 (19.8	)
Dizziness		20 (18.7	)		11 (10.8	)		6 (5.7	)
Headache		15 (14.0	)		15 (14.7	)		16 (15.1	)
Nausea		14 (13.1	)		8 (7.8	)		10 (9.4	)
Diarrhea		11 (10.3	)		14 (13.7	)		7 (6.6	)
Somnolence		11 (10.3	)		9 (8.8	)		10 (9.4	)
Fatigue		9 (8.4	)		11 (10.8	)		9 (8.5	)
Nasopharyngitis		9 (8.4	)		6 (5.9	)		8 (7.5	)
Constipation		7 (6.5	)		7 (6.9	)		9 (8.5	)
Muscle Spasms		7 (6.5	)		8 (2.0	)		10 (9.4	)

The proportion of patients reporting at least one serious adverse event (SAE) was 6.5% in the Zenvia 30/10 mg group, 8.8% in the Zenvia 20/10 mg group and 10.4% in the placebo group. A total of 38 SAEs occurred in 27 patients over the course of the study. Of the 38 SAEs reported in the study, only two were deemed by the investigators to be possibly or probably treatment-related; zero in the Zenvia 30/10 mg group, two in the Zenvia 20/10 mg group and zero in the placebo group. In addition, there was a numerical difference in respiratory SAEs with five patients (4.7%) in the Zenvia 30/10 mg group, three patients (2.9%) in the Zenvia 20/10 mg group and two patients (1.9%) in the placebo group experiencing respiratory SAEs.

Overall, there were seven deaths in the study, all in patients with underlying ALS. In total, three deaths occurred in the Zenvia 30/10 mg arm, three in the 20/10 mg arm and one in the placebo arm. Of the seven deaths that were reported, five of the deaths (four in the Zenvia treatments arms and one in the placebo arm) occurred at least five days after study drug had been discontinued. There was one reported death in the Zenvia 20/10 mg

group that was considered possibly treatment-related, which occurred five days after study drug had been discontinued.

During the study, there were no significant changes observed in laboratory values from baseline to end of study in any treatment group. In order to evaluate the potential for respiratory depression, nocturnal oxygen saturation was measured. There was a decrease in mean nocturnal oxygen saturation of 0.7% in the Zenvia 20/10 mg group (p=0.0472); however, no difference was observed in the higher 30/10 mg dose group relative to placebo.

CARDIOVASCULAR SAFETY

During the course of the study, no new cardiovascular safety signals were observed. There were no clinically meaningful changes in QT interval, no reported pro-arrhythmic events and no reports of any cardiovascular SAEs.

Electrophysiological Measures

	Zenvia 30/10 mg			Zenvia 20/10 mg			Placebo
Analysis of Central Tendency	N = 107			N = 102			N = 106
Mean QTc — Baseline (QTcB/QTcF)		418.3 / 407.0			416.2 / 403.8			415.9 / 404.8
Mean QTc — Day 84 (QTcB/QTcF)		420.8 / 411.6			413.2 / 404.6			416.9 / 406.0
Mean D in Baseline to Day 84 (QTcB/QTcF)		3.0 / 4.9			-1.9 / 1.2			1.5 / 1.1
Outlier Categorical Analysis (Visit 2 through Visit 5)*
Absolute > 450 msec (QTcB/QTcF)		6.3% / 1.9	%		4.9% / 1.2	%		6.1% / 2.4	%
Absolute > 480 msec (QTcB/QTcF)		0.2% / 0.0	%		0.0% / 0.0	%		0.9% / 0.0	%
Absolute > 500 msec (QTcB/QTcF)		0.0% / 0.0	%		0.0% / 0.0	%		0.2% / 0.0	%
D 30 — 60 msec (QTcB/QTcF)		7.0% / 7.2	%		3.9% / 2.9	%		6.6% / 3.5	%
D > 60 msec (QTcB/QTcF)		0.5% / 0.0	%		0.2% / 0.0	%		0.5% / 0.5	%
D > 90 msec (QTcB/QTcF)		0.0% / 0.0	%		0.0% / 0.0	%		0.0% / 0.0	%

* Percent of EKGs taken over the course of the study

“Overall, the STAR data would suggest that the new low dose formulation of Zenvia provides an improved safety and tolerability profile relative to the previous formulation,” said Randall Kaye, MD, Avanir‘s Chief Medical Officer. “We look forward to receipt and analysis of the full data set from the double blind phase of the STAR trial as well as results from the open-label extension study to further evaluate the safety and efficacy of the new dose formulations.”

CONFERENCE CALL

Avanir management will hold a conference call to discuss this announcement today at 5:00 AM PST (8:00 AM EST). Domestic investors may listen to the call by dialing (877) 558-3407, passcode 24703376, five to 10 minutes before the start of the call. International investors may listen to the call by dialing (706) 679-1941, passcode 24703376. A replay of the conference call will be available within a few hours after the call ends. Investors may listen to the replay by dialing (800) 642-1687, confirmation code 24703376. Today’s conference call also will be webcast and can be accessed at www.avanir.com. Investors interested in listening to the live webcast should log on before the conference call begins to download any software required. Both the audio replay and the archive of the conference call webcast will remain available for several days.

STAR TRIAL DESIGN

The STAR (Safety, Tolerability and Efficacy Results of AVP-923 in PBA) trial is a confirmatory Phase III trial of Zenvia in patients with pseudobulbar affect (PBA). The randomized, multi-center, international STAR trial compares active treatment with Zenvia 30/10 mg BID and Zenvia 20/10 mg BID to placebo during a three- month, double-blinded phase, followed by a three-month, open-label extension study. At the conclusion of enrollment, Avanir had enrolled a total of 326 patients (197 with underlying ALS and 129 with underlying MS) who exhibited signs and symptoms of PBA across 52 sites in the U.S. and Latin America. A total of 110, 107 and 109 patients were randomized to the Zenvia 30/10 mg group, the Zenvia 20/10 mg group and the placebo group, respectively. The primary efficacy analysis is based on the changes in crying/laughing episode rates recorded in patient diaries. Secondary endpoints for this clinical trial include: 1) Center for Neurologic Study-Lability Scale (CNS-LS) score; 2) Neuropsychiatric Inventory Questionnaire (NPI-Q); 3) SF-36 Health Survey; 4) Beck Depression Inventory (BDI-II); and 5) Pain Rating Scale score (MS patients only). Safety and tolerability of Zenvia are determined by reporting adverse events, physical exam, vital signs, electrocardiogram, respiratory function tests and clinical assessment of clinical laboratory variables. The STAR trial is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA). For more information visit www.pbatrial.com.

ABOUT PBA

Pseudobulbar affect (PBA), also known as emotional lability, is a neurologic disorder that occurs secondary to neurologic disease or brain injury causing sudden and unpredictable episodes of crying, laughing, or other emotional displays. PBA is estimated to impact approximately 2 million people in the United States with underlying neurologic conditions such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Parkinson’s disease, dementias including Alzheimer’s disease, stroke, and traumatic brain injury. PBA episodes may occur when disease or injury damages the area of the brain that controls normal expression of emotion. This damage can disrupt brain signaling causing a “short circuit” and triggering involuntary PBA episodes. PBA has been shown to impair the lives of patients in both social and occupational settings. There are currently no FDA approved treatments for PBA.

ABOUT ZENVIA

Zenvia™ (dextromethorphan/quinidine) is a combination of two well-characterized compounds: the therapeutically active ingredient dextromethorphan and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan. This first-in-class drug candidate is believed to help regulate excitatory neurotransmission in two ways: through pre-synaptic inhibition of glutamate release via sigma-1 receptor agonist activity and through postsynaptic glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity. Zenvia is being developed for the treatment of pseudobulbar affect (PBA) and has successfully completed a Phase III trial for diabetic peripheral neuropathic (DPN) pain. In October 2006, the Company received an approvable letter for Zenvia in the treatment of PBA. The Company is conducting a confirmatory Phase III study under a Special Protocol Assessment (SPA) agreement with the FDA utilizing a new lower quinidine dose formulation of Zenvia intended to address safety concerns raised in the Agency’s approvable letter for Zenvia in the treatment of PBA. For more information about this trial visit http://www.pbatrial.com, and for more information about the Agency’s SPA process, see http://www.fda.gov/cder/guidance/3764fnl.htm. In addition, Avanir has conducted a Phase III study of Zenvia in DPN pain where the primary endpoints were successfully met. Subsequently the Company released top-line results of a formal PK study that identified alternative lower-dose quinidine formulations of Zenvia for DPN pain intended to deliver similar efficacy and improved safety/tolerability versus the formulations previously tested for this indication. Avanir is now engaged in discussions with the FDA under the SPA process regarding the design of the next Phase III study in DPN pain and overall program requirements.

ABOUT Avanir

Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing novel therapeutic products for the treatment of central nervous system disorders. Avanir‘s lead product candidate, Zenvia, is being developed for the treatment of pseudobulbar affect (PBA) and has successfully completed a Phase III trial for diabetic peripheral neuropathic (DPN) pain. Avanir has licensed its MIF inhibitor program to Novartis International Pharmaceuticals Ltd. and has sold its anthrax monoclonal antibody program to Emergent BioSolutions. The Company’s first commercialized product, Abreva^® (docosanol), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about Avanir can be found at www.avanir.com and further information about pseudobulbar affect can be found at www.PBAinfo.org.

FORWARD LOOKING STATEMENTS

Statements in this press release that are not historical facts, including statements that are preceded by, followed by, or that include such words as “estimate,” “intend,” “anticipate,” “believe,” “plan,” “goal,” “expect,” “project,” or similar statements, are forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from the future results expressed or implied by such statements. For example, there can be no assurance that the U.S. Food and Drug Administration (FDA) will approve Zenvia for any indication, that subsequent complete analysis of clinical data will be consistent with the preliminary top-line data reported herein, or that the Company will meet projected clinical or regulatory timelines. Risks and uncertainties affecting the Company’s financial condition and operations also include the risks set forth in Avanir‘s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and from time-to-time in other publicly available information regarding the Company. Copies of this information are available from Avanir upon request. Avanir disclaims any intent to update these forward-looking statements.

To be included on Avanir‘s e-mail alert list; click on the link below or visit Avanir‘s website:
http://www.b2i.us/irpass.asp?BzID=958&to=ea&s=0

Avanir Investor Contacts
Eric Benevich
Brenna Mullen
ir@avanir.com
(949) 389-6700

EX-99.2

Exhibit 99.2

STAR Trial Results Conference Call August 11, 2009

Forward-looking Statement This presentation contains forward-looking statements concerning future events and performance of our Company. These statements can be identified by words or phrases such as, "believe," "expect," "will," and "may". Readers are cautioned against placing reliance on these forward looking statements because they are only statements of our current expectations based on assumptions and actual results may be different. Many known and unknown risks and uncertainties could cause our actual results to differ materially from those indicated in these forward-looking statements. For example, there can be no assurance that the U.S. Food and Drug Administration (FDA) will approve Zenvia for any indication, that subsequent complete analysis of clinical data will be consistent with the preliminary top-line data reported herein, that the Company will be able to secure additional worldwide intellectual property protection for its Zenvia patent portfolio or that any Zenvia clinical development programs for indications other than pseudobulbar affect will move forward without additional capital or partnerships. There can also be no assurance that the Company's existing capital will be sufficient to fund operations through the expected timing of an approval decision from the FDA on the PBA application. Other risks and uncertainties are set forth in, and forward-looking statements in this presentation should be reviewed in conjunction with, the Company's most recent Annual Report on Form 10-K, subsequent quarterly reports on Form 10- Q and other publicly available information regarding the Company, copies of which are available from the Company upon request. The Company disclaims any intent to update these forward-looking statements. 2

3 Keith Katkin ^ President and Chief Executive OfficerRandall Kaye, MD ^ Chief Medical Officer Avanir Participants

Summary of STAR Trial Results Zenvia(tm) 30/10 mg met its primary endpoint demonstrating efficacy in the treatment of pseudobulbar affect (PBA)Zenvia(tm) 20/10 mg also met the secondary analysis of the primary endpoint demonstrating efficacy in the treatment of pseudobulbar affect (PBA)Both doses of Zenvia were generally safe and well toleratedThe incidence of adverse events was improved versus what has been reported for the previous 30/30 mg formulationBoth doses of Zenvia demonstrated a satisfactory cardiovascular safety profileNo clinically meaningful changes in QT intervalNo reported pro-arrhythmic events No reports of cardiovascular serious adverse events 4

PBA Market Overview Keith Katkin

PBA Clinical Overview Neurologic disorder causing involuntary emotional outburstsCrying, laughing or other emotional displaysAssociated with numerous neurologic diseases or injuriesAlzheimer's disease Amyotrophic lateral sclerosis (ALS)Multiple sclerosis (MS)Parkinson's diseaseStrokeTraumatic brain injuryEpisodes can be frequent, severe and cause impairment 6

(CHART) PBA: A Significant Health Burden SF-36 Health Status Survey Scores * Significant differences at p<.051 PBA Burden of Illness Study, Avanir Pharmaceuticals - data on file 2 US norms reported for select chronic conditions - data on file 3 PBA Burden of Illness Study - patients without PBA symptoms, matched for age and gender and adjusted for underlying disease severity 1 7 * * 1 2 2 Best Health Poorest Health PBA Cases vs. Other Conditions PBA Impact on Health Status Compared to matched neurologic controls3, PBA patients reported:Worse physical and mental healthWorse physical and social functionWorse quality of life and relationshipsGreater likelihood to experience daily activity and workplace impairments

U.S. PBA Market U.S. PBA Populations1 U.S. PBA Populations1 Market Characteristics Estimated 2 million in U.S. with moderate / severe PBA1No approved PBA therapiesLow physician satisfaction with off-label treatments2Concentrated prescriber base appropriate for a small specialty sales force 8 Approximately 2 million patients with unmet medical need 1 Poster P01.090: "Involuntary Emotional Expression Disorder (PBA) Prevalence and Treatment" presented at AAN, 2007, and data on file.2 Zenvia Physician Market Research

STAR Trial Results Randall Kaye, MD

Confirmatory Phase III STAR* Trial 10 * The Safety, Tolerability And Efficacy Results of AVP-923 in PBA Randomized n = 107 n = 326 Placebo BID Zenvia 30/10 mg BID n = 110 n = 109 Zenvia 20/10 mg BID PopulationsMS (n=129)ALS (n=197)Primary EndpointCrying / Laughing RatesSecondary EndpointsCNS-LS scoreSF-36 Health StatusNeuropsychiatric InventoryBeck Depression InventoryPain (MS patients only)Additional InformationConducted under SPA~ 60 sites> 90% power to detect 36% reduction beyond placebo 12 Weeks Blinded Phase 12 Weeks OLE Phase n = 253

STAR Trial - Efficacy Endpoints 11 Endpoint Description PBA Episode Rate (primary endpoint) Changes from baseline in laughing/crying episodes rates recorded in the patient diary Center for Neurologic Study - Lability Scale (CNS-LS) A 7 question validated scale that provides a score for total PBA intensity and severity SF-36 Health Survey A 36 question validated scale used to assess health status Neuropsychiatric Inventory Questionnaire (NPI-Q) A brief questionnaire covering 12 neuropsychiatric symptom domains Beck Depression Inventory A 21-item self-report instrument assessing the existence and severity of symptoms of depression Pain Rating Scale (MS patients only) Patients rate their pain over the past 12 hours on a scale of 0-10 (0 = none, 10 = worst pain ever experienced) Caregiver Strain Index A self-administered 13-question tool that measures strain related to care provision

Demographics 12 Avanir data on file Characteristic Zenvia 30/10 n = 110 Zenvia 20/10 n = 107 Placebo n = 109 Mean Age, years (SD) 53.1 (11.0) 50.8 (11.1) 50.3 (11.9) Gender Male 46 (41.8%) 53 (49.5%) 50 (45.9%) Female 64 (58.2%) 54 (50.5%) 59 (54.1%) Race Caucasian 80 (72.7%) 80 (74.8%) 83 (76.1%) Black 6 (5.5%) 2 (1.9%) 4 (3.7%) Hispanic 21 (19.1%) 21 (19.6%) 21 (19.3%) Other 3 (2.7%) 4 (3.7%) 1 (0.9%) Country U.S. 76 (69.1%) 71 (66.4%) 75 (68.8%) Latin America 34 (30.9%) 36 (33.6%) 34 (31.2%)

Baseline Characteristics 13 Avanir data on file Characteristic Zenvia 30/10 n = 110 Zenvia 20/10 n = 107 Placebo n = 109 Mean PBA episodes/day (SD) 4.7 (9.5) 6.8 (12.9) 4.5 (7.6) Mean PBA episodes/week 32.6 47.3 31.2 Mean Baseline CNS-LS score (SD) 19.8 (4.9) 21.0 (5.0) 19.9 (4.7) Underlying Disease ALS 65 (59.1%) 68 (63.6%) 64 (58.7%) MS 45 (40.9%) 39 (36.4%) 45 (41.3%)

Patient Disposition 14 Avanir data on file Baseline Characteristic Zenvia 30/10 n = 110 Zenvia 20/10 n = 107 Placebo n = 109 Subjects Dosed 107 (97.3%) 102 (95.3%) 106 (97.2%) Completed Study 100 (90.9%) 88 (82.2%) 94 (86.2%) Discontinued 9 (8.2%) 19 (17.8%) 15 (13.8%) Adverse Event (AE) 1 (0.9%) 5 (4.7%) 0 (0.0%) Medication refusal due to AE 2 (1.8%) 2 (1.9%) 0 (0.0%) Serious Adverse Event 2 (1.8%) 3 (2.8%) 1 (0.9%) Withdrew consent 2 (1.8%) 2 (1.9%) 7 (6.4%) Lost to follow-up 1 (0.9%) 3 (2.8%) 2 (1.8%) Other (all) 1 (0.9%) 4 (3.8%) 5 (4.6%)

Treatment Effect Treatment Effect Significant Efficacy 15 Both the Zenvia 30/10 mg and 20/10 mg significantly reduced PBA episodes Avanir data on file Over the course of the study, both Zenvia 30/10 mg and Zenvia 20/10 mg demonstrated a significant reduction in PBA episode rates when compared to placebo (p<0.0001) Primary Endpoint: Reduction of PBA Episodes from Baseline Percent Treatment Effect

Primary Endpoint: Reduction of PBA Episodes Reduction of PBA Episodes Reduction of PBA Episodes 16 At week 12 (end of study), patients receiving Zenvia 30/10 mg reported a mean reduction of 88% from baseline PBA episode rates Avanir Data on File PBA Episode Rates Over Time by Treatment Group P < 0.0001 for Zenvia 30/10 mg vs. placebo across all time points

Primary Endpoint: Reduction of PBA Episodes Reduction of PBA Episodes Reduction of PBA Episodes 17 Zenvia 30/10 mg and Zenvia 20/10 mg provided a statistically significantly reduction of PBA episode rates over the course of the study compared to placebo Avanir Data on File Reduction in PBA Episode Rates Over Time by Treatment Group * P ^0.01 for Zenvia 30/10 mg vs. placebo at each visit * * * * ** ** ** ** ** P ^0.006 for Zenvia 20/10 vs. placebo at each visit

Secondary Endpoint: Improvements in CNS-LS Score CNS-LS Score1 CNS-LS Score1 Significant Efficacy 18 Zenvia 30/10 mg decreased the intensity and severity of PBA Zenvia 30/10 mg demonstrated a significantly greater decrease in CNS-LS score compared to placebo (p=0.0002)Zenvia 20/10 mg demonstrated a significantly greater decrease in CNS-LS score compared to placebo (p=0.01) Avanir data on file1The Center for Neurologic Study Lability Scale (CNS-LS) is a validated instrument measuring the frequency and severity of PBA episodes More Severe PBA Less Severe PBA

Secondary Endpoint: Improvements in CNS-LS Score Improvements in CNS-LS Score Improvements in CNS-LS Score 19 Zenvia 30/10 mg decreased the intensity and severity of PBA Avanir Data on File CNS-LS Scores Over Time by Treatment Group * P ^0.001 for Zenvia 30/10 mg vs. placebo at each visit * * * * ** ** ** P ^0.01 for Zenvia 20/10 mg vs. placebo at each visit

Safety 20 Summary Analysis of Adverse Events (AEs) Avanir data on file Adverse Event Zenvia 30/10 n = 107 Zenvia 20/10 n = 102 Placebo n = 106 Number of AEs 334 286 295 Patients with at least one AE 89 (83.2%) 82 (80.4%) 86 (81.1%) Patients who discontinued due to an AE 4 (3.7%) 8 (7.8%) 2 (1.9%) Patients with an SAE 7 (6.5%) 9 (8.8%) 11 (10.4%) Patients with SAE related to study drug 0 (0.0%) 2 (2.0%) 0 (0.0%) Patients who died 3 (2.8%) 3 (2.9%) 1 (0.9%)

Adverse Events 21 AEs ^ 5% - by Treatment Group Avanir data on file Adverse Event Zenvia 30/10 n = 107 Zenvia 20/10 n = 102 Placebo n = 106 Falls 22 (20.6%) 14 (13.7%) 21 (19.8%) Dizziness 20 (18.7%) 11 (10.8%) 6 (5.7%) Headache 15 (14.0%) 15 (14.7%) 16 (15.1%) Nausea 14 (13.1%) 8 (7.8%) 10 (9.4%) Diarrhea 11 (10.3%) 14 (13.7%) 7 (6.6%) Somnolence 11 (10.3%) 9 (8.8%) 10 (9.4%) Fatigue 9 (8.4%) 11 (10.8%) 9 (8.5%) Nasopharyngitis 9 (8.4%) 6 (5.9%) 8 (7.5%) Constipation 7 (6.5%) 7 (6.9%) 9 (8.5%) Muscle Spasms 7 (6.5%) 8 (2.0%) 10 (9.4%) Note: A decrease in mean nocturnal oxygen saturation of 0.7% was observed in the Zenvia 20/10 mg group (p=0.0472); however, no difference was observed in the higher 30/10 mg dose group

Serious Adverse Events 38 SAEs occurred in 27 patients over the course of the studySeven deaths occurred in the study, all in the ALS populationThree deaths were reported in the 30/10 mg group, three in the 20/10 mg group and one in the placebo groupFive of the deaths (four in the Zenvia treatments arms and one in the placebo arm) occurred at least five days after study drug had been discontinuedOne death in the 20/10 mg group was reported as possibly treatment-related which occurred five days after study drug had been discontinued 22 Avanir data on file Treatment Arm Total SAEs Reported % Patients Reporting ^ 1 SAE SAEs Possibly / Probably Related to Treatment % Patients Reporting Respiratory SAEs Zenvia 30/10 mg 11 6.5% 0 4.7% Zenvia 20/10 mg 14 8.8% 2 2.9% Placebo 13 10.4% 0 1.9%

Cardiovascular Safety 23 Avanir data on file* Percent of EKGs taken over the course of the study Analysis of Central Tendency Zenvia 30/10 Zenvia 20/10 Placebo Mean QT - Baseline (QTcB/QTcF) 418.3 / 407.0 416.2 / 403.8 415.9 / 404.8 Mean QT - Day 84 (QTcB/QTcF) 420.8 / 411.6 413.2 / 404.6 416.9 / 406.0 Mean ^ in Baseline to Day 84 (QTcB/QTcF) 3.0 / 4.9 -1.9 / 1.2 1.5 / 1.1 Outlier Categorical Analysis (visit 2 through visit 5)* Outlier Categorical Analysis (visit 2 through visit 5)* Outlier Categorical Analysis (visit 2 through visit 5)* Outlier Categorical Analysis (visit 2 through visit 5)* Absolute > 450 msec (QTcB/QTcF) 6.3% / 1.9% 4.9% / 1.2% 6.1% / 2.4% Absolute > 480 msec (QTcB/QTcF) 0.2% / 0.0% 0.0% / 0.0% 0.9% / 0.0% Absolute > 500 msec (QTcB/QTcF) 0.0% / 0.0% 0.0% / 0.0% 0.2% / 0.0% ^ 30 - 60 msec (QTcB/QTcF) 7.0% / 7.2% 3.9% / 2.9% 6.6% / 3.5% ^ > 60 msec (QTcB/QTcF) 0.5% / 0.0% 0.2% / 0.0% 0.5% / 0.5% ^ > 90 msec (QTcB/QTcF) 0.0% / 0.0% 0.0% / 0.0% 0.0% / 0.0%

Safety Summary Both doses of Zenvia were generally safe and well toleratedThe most commonly reported adverse events that appeared to be more frequent than in placebo were dizziness, nausea and diarrheaBoth doses of Zenvia demonstrated a satisfactory safety profileNo clinically meaningful changes in QT intervalNo reported pro-arrhythmic eventsNo cardiovascular SAEsFull safety database, including the open-label study, will continue to be evaluated as additional data becomes available 24

Conclusions Top-line STAR data indicate that the new Zenvia 30/10 mg dose offers:Statistically significant and clinically meaningful efficacyAn improved tolerability and safety profile compared to the previous formulationWe expect that the full STAR trial dataset, combined with additional clinical and pre-clinical data, will be sufficient to address the issues outlined in the FDA approvable letter 25

Next Steps Keith Katkin

Comparison of Product Profiles 27 Based on the STAR top-line data and the Advanced Cardiac Safety Study, Zenvia 30/10 mg appears to offer an improved risk / benefit balance 1 STAR trial - Avanir data on file; end of study compared to baseline2 Avanir studies 99-AVR-102 (ALS) and 02-AVR-106 (MS) Characteristic Zenvia 30/10 mg Zenvia 30/30 mg Reduction in PBA episodes 88% ^ from baseline1 79-95% ^ from baseline2 AEs - Nausea 13.1%1 22-33%2 AEs - Dizziness 18.7%1 20-26%2 AEs - Fatigue 8.4%1 14-19%2 All-cause Discontinuations 9.1%1 26-28%2 Discontinuations due to AEs 3.7%1 14-24%2 Max-Mean ^ QTcF 10.4 msec3 10.1 msec4 QTcF Outliers: ECGs ^ >30 msec 0.5%3 4.2%4 QTcF Outliers: Patients ^ >30 msec 6.0%3 22.0%4 3 Advanced Cardiac Safety Study - Avanir data on file4 Thorough QT Study - Avanir data on file

Zenvia 30/10: An Enhanced Regulatory Package The Zenvia PBA clinical program features an extensive databaseOver 30 pre-clinical and clinical studies spanning a 10 year periodThe complete response filing will feature a >95% increase in the number of subjects compared to the 2006 NDA839 subjects exposed to DM/Q were included in the NDA filing1636 subjects exposed to DM/Q will be included in the full responseOver 500 patient-years of safety data will be included in the full response 28

PBA Program Timeline 29 2009 Last patient in - Phase III STAR trial in PBA Top-line results - Phase III STAR trial in PBAFull Double blind STAR data presented at scientific meetingOpen label safety study in PBA completed ? 2010 Full response to PBA approvable letterFDA approval decision on PBA application ?

Zenvia PBA Program Summary 30 Large market opportunityNo competitionSignificant unmet medical need Commercialization Improved overall risk-benefitData to address approvable letterEnhanced regulatory package Regulatory Strong top-line resultsSignificant clinical efficacyImproved safety and tolerability STAR Trial

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