AVANIR Pharmaceuticals presents Phase III trial data of Zenvia for PBA at AAN Annual Meeting

AVANIR Pharmaceuticals, Inc. (NASDAQ:AVNR) today announced the presentation of detailed data, including safety and tolerability data from the open-label extension as well as cardiac safety data from the double-blind phase of the Phase III confirmatory STAR trial evaluating the investigational drug Zenvia™ (dextromethorphan/quinidine) in the treatment of pseudobulbar affect (PBA). The data were presented in two posters at the American Academy of Neurology (AAN) Annual Meeting in Toronto, Canada.

“We are pleased to present these important data at the AAN Annual Meeting and are very satisfied with the safety and tolerability profile that Zenvia demonstrated in both the double-blind and open-label extension phases of the STAR trial”

"We are pleased to present these important data at the AAN Annual Meeting and are very satisfied with the safety and tolerability profile that Zenvia demonstrated in both the double-blind and open-label extension phases of the STAR trial," said Randall Kaye, MD, AVANIR's Chief Medical Officer. "The new lower dose formulations of Zenvia have maintained statistically significant and clinically meaningful efficacy while providing an improved safety and tolerability profile relative to the original higher dose formulation. We plan to file our full response with the FDA within the next few weeks and expect an approval decision on the PBA application before the end of this year."

POSTER HIGHLIGHTS: SAFETY AND TOLERABILITY - OPEN-LABEL EXTENSION

• In PBA patients treated for up to 24 weeks (12 double-blind weeks and 12 open-label weeks) Zenvia 30/10 mg was generally safe and well-tolerated
• In the open label extension of the STAR trial, no new safety concerns emerged

SAFETY AND TOLERABILITY OF ZENVIA IN OPEN LABEL STUDY (Poster Number: P06:128)

Of the 283 patients completing the 12-week double-blind phase of the STAR trial, 253 patients (or 89.4%) entered the open-label extension; 94 who originally received Zenvia 30/10 mg, 76 who originally received Zenvia 20/10 mg and 83 who originally received placebo. Demographically and by underlying disorder, the open-label cohort resembled the groups in the preceding double-blind phase of the trial. All patients enrolled into the open-label study within two weeks of completing the double-blind phase and received the Zenvia 30/10 mg dose twice daily. A total of 235 patients (or 92.9%) completed the open-label study.

POSTER HIGHLIGHTS: CARDIAC SAFETY - DOUBLE BLIND

• In patients receiving either Zenvia 30/10 mg or 20/10 mg, mean changes in QTc interval were < 5 msec
• In patients receiving either Zenvia 30/10 mg or 20/10 mg, no absolute or change in QTc exceeded 500 msec or 60 msec respectively and no new cardiac safety signals emerged
• In the STAR trial there were no reports of pro-arrhythmic events or cardiovascular serious adverse events (SAEs)

SUMMARY OF CARDIAC SAFETY FROM STAR TRIAL (Poster Number: P06:119)

The STAR trial was a 12-week, double-blind, confirmatory Phase III trial of Zenvia in the treatment of PBA in patients with underlying multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS). The STAR trial compared active treatment with Zenvia 30/10 mg and Zenvia 20/10 mg to placebo. At baseline and on days 15, 29, 57, and 84 (end of study), 12-lead ECGs were obtained. QT-interval length was calculated with correction for heart rate by Bazett's formula and by Fridericia's formula (QTcB and QTcF). At baseline, the treatment groups had similar demographics, similar PBA severity and similar QTc interval length. In all treatment groups, mean changes in QTcB and QTcF were <5 msec. No patients had QTc intervals >500 msec at day 84, and no patients had increases >60 msec in either QTcB or QTcF.