ALISO VIEJO, Calif., April 28, 2014 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that data from its CNS therapeutics franchise, specifically in its pseudobulbar affect (PBA) and migraine development programs will be presented at the 66 th American Academy of Neurology (AAN) Annual Meeting in Philadelphia. In addition, an article in the peer-reviewed publication, US Neurology, discussing PBA diagnosis in patients with Alzheimer's disease (AD) and other dementias, will be available at AAN and was recently published online. The AAN presentations and US Neurology publication offer important new insights into the prevalence, diagnosis, impact and treatment of PBA, a distressing neurological condition characterized by uncontrollable laughing or crying. Data from the pivotal phase III trial of AVP-825, an investigational drug-device combination product for the acute treatment of migraine will also be presented.
"Collectively these data reflect our commitment to advancing innovative medicines for treating central nervous system disorders with high unmet medical need such as PBA and migraine," said Joao Siffert, M.D., chief medical officer at Avanir. "In particular, the data presented highlighted the potential ability of NUEDEXTA to provide PBA symptom remission quickly after initiation of therapy, whereas the pivotal migraine study, which supported our filing with the U.S. Food and Drug Administration, highlighted unique attributes of AVP-825 that provide rapid migraine relief with good tolerability. We look forward to FDA's decision on our submission for AVP-825 that is set for November 26, 2014."
New Data Demonstrate that NUEDEXTA may Provide Early PBA Symptom Remission
"Sudden, uncontrollable outbursts of crying or laughter negatively impact patients' quality of life and take an emotional toll on not only the patients but also their loved ones," said Benjamin Brooks, M.D., Director, Carolinas Neuromuscular/ALS-MDA Center at Carolinas Healthcare System and Professor of Neurology, University of North Carolina School of Medicine – Charlotte Campus. "NUEDEXTA is the only medication specifically designed and approved to treat PBA, and these new data show that NUEDEXTA can provide symptomatic remission in more than half of treated patients, with 19 percent achieving remission after the first week."New post-hoc analysis from the Phase III STAR Trial comparing NUEDEXTA to placebo in the treatment of PBA showed that 19 percent of patients treated with NUEDEXTA achieved remission from their PBA symptoms after only one-week of treatment. This percentage increased to approximately 50 percent achieving remission by the end of the 12-week trial. Throughout the trial, sustained episode remission rates in patients treated with NUEDEXTA were significantly higher compared to placebo. Remission was defined as no episodes for the remainder of the study and a minimum of 14 days prior to completion or drop-out.
- Oral Presentation Details: Title: Dextromethorphan and Quinidine for Treatment of Pseudobulbar Affect (PBA): Time Course of PBA Episode RemissionAbstract Number: S31.007Session: S31 Platform Session: General Neurology ITime: Wednesday, April 30, at 3:30 p.m. Eastern Time (ET)
- Presentation Details: Title: Study of Pseudobulbar Affect Symptoms in Veterans With Mild Traumatic BrainAbstract Number: P5.341Session: P5: Poster Session V: Neuro Trauma, Critical Care, and Sports Neurology: Outcomes Time: Wednesday, April 30, at 3-6:30 p.m. ET
- Presentation Details:Title: Efficacy and Safety of AVP-825, a Novel Breath-Powered™ Powder Sumatriptan Intranasal Treatment, for Acute MigraineAbstract Number: P7.203Data Blitz Session: I9: INS Data Blitz: Emerging Concepts in Headache TherapyData Blitz Time: Thursday, May 1 at 4:35 p.m. ETPoster Session: P7: Poster Session VII: Headache: TreatmentPoster Time: Thursday, May 1 from 3-6:30 p.m. ET
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