Pharmaceutical News

AVANIR Pharmaceuticals, Inc. news.
Date Posted: 09 October 2009

AVANIR Pharmaceuticals, Inc. (NASDAQ:AVNR) today announced additional detailed results from the confirmatory double-blind Phase III STAR trial evaluating two doses of the investigational drug Zenvia™ (dextromethorphan/quinidine) compared to placebo in the treatment of pseudobulbar affect (PBA) among patients with underlying multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS). Over the course of the 12-week study in the MS patient subset, Zenvia 30/10 mg met the primary efficacy endpoint by reducing PBA episode rates by an incremental 11.9% beyond placebo (p=0.0280). The lower dose Zenvia 20/10 mg group did not achieve a statistically significant reduction in PBA episode rates compared to placebo. These results were presented today during a late-breaker poster session at the 3rd World Congress on Controversies in Neurology in Prague, Czech Republic (Poster Number: 11). Efficacy Highlights – MS Cohort: Zenvia 30/10 mg dose met the primary endpoint in the subset of patients with underlying MS by significantly reducing PBA episode rates compared to placebo Both Zenvia groups demonstrated a numerical reduction in mean CNS-LS scores but did not achieve statistical significance versus placebo in this small subset of MS patients Zenvia 30/10 mg demonstrated relief of MS-related pain in the subset of MS patients with moderate-to-severe pain “PBA represents an area of high unmet medical need with no FDA-approved treatments currently available. Although the involuntary emotional outbursts of PBA cause considerable impairment for millions of individuals in the United States, it is under recognized and commonly misdiagnosed,” said poster presenter Daniel Wynn, MD, Director, Clinical Research, Co-Director, Consultants in Neurology Multiple Sclerosis Center and STAR Trial Steering Committee member. “If approved, Zenvia will be an important treatment option to ameliorate the profound distress caused by PBA among individuals afflicted with neurologic disease or injury and their caregivers.” “We were very pleased that Zenvia demonstrated significant improvement in PBA episodes in the MS sub-population as well as encouraging proof of concept data in MS-related pain,” said Randall Kaye, MD, AVANIR’s Chief Medical Officer. “This is especially exciting given that the STAR trial was not powered to detect an efficacy signal in such a small number of patients. These data provide additional insight into the clinical utility of Zenvia and help shape our plans for future drug development.” ADDITIONAL EFFICACY RESULTS An important pre-specified secondary endpoint was the reduction of pain associated with MS using the 11-point Pain Rating Scale (PRS). All MS patients enrolled in the study assessed their daily pain regardless of baseline pain level or use of concomitant analgesics. Mean pain scores in MS patients (all patients regardless of baseline pain score) were decreased from baseline across time in the Zenvia 30/10 mg group. Mean scores at days 15 and 29 showed trends for superiority of Zenvia 30/10 mg over placebo (p=0.0512 and p=0.0859, respectively). In an additional preliminary analysis that included only MS patients with moderate-to-severe pain at baseline (PRS score =4), mean PRS scores in the Zenvia 30/10 mg group were significantly lower than those in the placebo group on days 29, 57, and 84. Data from this important secondary efficacy endpoint are summarized in the following table: PRS Scores Across Time in MS Patients With Baseline Score =4 (ITT Population)aStudy Visit   Zenvia 30/10 mg n = 26   Placebo n = 22   p-valueb Baseline   5.62 (1.53)   5.85 (1.75)   0.33 Day 15   2.74 (2.66)   2.99 (2.54)   0.24 Day 29   2.42 (2.63)   2.92 (2.67)   0.01 Day 57   2.02 (2.49)   2.68 (2.57)   <0.0001 Day 84   …
Read the full article

:end
______________________________________________________________________
This outbound email has been scanned by the MessageLabs Security System.
______________________________________________________________________