Key Developments For Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. (AVNR.O) (Consolidated Issue listed on NASDAQ Global Market)
Avanir Pharmaceuticals Announces Zenvia Safety And Efficacy Data From Star Trial Open Label Extension
Avanir Pharmaceuticals announced the efficacy, safety and tolerability results from the 12 week open label extension phase of the confirmatory Phase III STAR trial evaluating the investigational drug Zenvia (dextromethorphan/quinidine) in the treatment of patients with pseudobulbar affect (PBA). - Patients maintained on Zenvia 30/10 mg demonstrated statistically significant incremental improvement in their CNS-LS scores over the additional 12-week treatment period of the open-label study (p<0.0001). - Patients that titrated from Zenvia 20/10 mg to Zenvia 30/10 mg demonstrated statistically significant incremental improvement in their CNS-LS scores (p<0.0001). - Patients originally on placebo that initiated Zenvia 30/10 mg demonstrated statistically significant improvement in their CNS- LS scores (p<0.0001). - Zenvia 30/10 mg was generally safe and well tolerated with 92.9% of patients completing the 12-week treatment period of the open-label study. - Reported rates of adverse events (AEs) were low overall, mild to moderate in nature and consistent with the reported AEs in the double-blind phase. - The overall mortality rate observed in patients with amyotrophic lateral sclerosis, or ALS, (a terminal condition) was consistent with historic norms.
Avanir Pharmaceuticals Announces Detailed Zenvia Confirmatory Phase III Results
Avanir Pharmaceuticals announced 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) in patients with underlying multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS). Over the course of the 12-week study, Zenvia 30/10 mg and 20/10 mg met the primary efficacy endpoint by reducing PBA episode rates by an incremental 47.2% and 47.8% respectively, beyond placebo (p<0.0001). Efficacy highlights include: both the Zenvia 30/10 mg and 20/10 mg groups met the primary efficacy endpoint by demonstrating a significant reduction in daily PBA episode rates relative to the placebo group; the proportion of patients with complete remission of PBA episodes was significantly greater in both Zenvia treatment groups versus placebo; the percent of days that were episode-free was significantly higher in the Zenvia groups versus placebo; Zenvia 30/10 mg demonstrated statistical superiority in time to onset of clinically meaningful effect; both Zenvia groups demonstrated a greater proportion of patients versus placebo that achieved response thresholds of 50%, 75% and 90% improvement; mean reduction from baseline in CNS-LS score was significantly greater for both Zenvia treatment groups than in the placebo group.
Avanir Pharmaceuticals Announces Zenvia Phase III Results In Multiple Sclerosis Patient Population At Controversies In Neurology Congress
Avanir Pharmaceuticals 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. 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. Overall, Zenvia was generally safe and well tolerated in the MS population. In the MS subset, the percent of patients completing the study was 93.3% for Zenvia 30/10 mg, 89.7% for Zenvia 20/10 mg, and 86.7% for placebo. Only 3 MS patients discontinued the study because of adverse events; all were in the Zenvia 20/10 mg group.
Avanir Pharmaceuticals Announces Receipt of Notice of Allowance of New U.S. Patent On Zenvia
Avanir Pharmaceuticals announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) announcing that it intends to grant the Company a new patent, extending the period of commercial exclusivity for its lead drug candidate Zenvia well into 2025. Upon issuance, U.S. patent application number 11/035,213 titled Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorders will provide AVANIR with patent protection for low-dose quinidine formulations of Zenvia used to treat pseudobulbar affect (PBA).
Avanir Pharmaceuticals Raises $10.6 Million Through Sale Of Common Stock
Avanir Pharmaceuticals announced it had raised gross proceeds of approximately $10.6 million via the sale of approximately 4.5 million shares of common stock at a weighted average price of $2.34 per share.
