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 66th 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 Remission Abstract Number: S31.007 Session: S31 Platform Session: General Neurology I Time: Wednesday, April 30, at 3:30 p.m. Eastern Time (ET)
New Data in Veterans with Traumatic Brain Injury (TBI) Highlights PBA Symptoms Impact on Quality of Life
New data from a first-of-its-kind study of PBA symptoms in veterans with mild TBI highlights the negative impact PBA symptoms have on quality of life, adding an extra burden to life post-TBI. In addition to patient burden, the data demonstrate that overall health care costs increased in these patients compared to TBI patients without PBA symptoms. Medication costs more than doubled in PBA symptom-positive veterans, and total outpatient healthcare costs were about 20% higher. These data highlight the need for developing a screening protocol for identifying PBA symptoms to help improve diagnosis, treatment and ultimately the quality of care for our nation's veterans. This study was conducted in collaboration with the Department of Veterans Affairs (VA) and Evidera.
Presentation Details: Title: Study of Pseudobulbar Affect Symptoms in Veterans With Mild Traumatic Brain Abstract Number: P5.341 Session: P5: Poster Session V: Neuro Trauma, Critical Care, and Sports Neurology: Outcomes Time: Wednesday, April 30, at 3-6:30 p.m. ET
PBA May Be Often Overlooked or Misdiagnosed in Dementia Patients Adding to the Potential Disease Burden
A sample case study discussion published online by US Neurology in April 2014 (available here) and available on-site during AAN, concluded that it is important for physicians to consider PBA when assessing patients with Alzheimer's disease or other dementias.
"Dementia patients, including those with Alzheimer's disease, commonly suffer from depression and neurobehavioral symptoms. Excessive crying episodes may actually be symptoms of PBA which can be overlooked or misdiagnosed," said David W. Crumpacker, M.D., Adult and Geriatric Psychiatry Private Practice Leader. "Proper diagnosis of PBA can make a major difference in patient management, by allowing patients, caregivers and physicians an opportunity to discuss and determine if targeted therapy with NUEDEXTA may be beneficial."
AVP-825 Demonstrates Rapid Migraine Relief
"Migraine is well accepted as a neurologic disease that has debilitating consequences, and for which new treatments are needed that can provide fast and effective relief," said Roger K. Cady, MD, Director of the Headache Care Center and Associate Executive Chairman of the National Headache Foundation. "AVP-825 is the first migraine treatment to deliver medicine using the Breath Powered intranasal device, and data show that it may be able to provide patients with fast and sustained headache relief with few adverse events."
In this multicenter, double-blind, placebo-controlled study, migraine sufferers were randomized to self-administer either AVP-825 or placebo using the Breath Powered device when they had moderate to severe migraine pain. The data show migraine headache relief for some patients began as early as 15 minutes after treatment, and a statistically significant greater number of patients receiving AVP-825 experienced headache relief compared to placebo at all time points from 30 minutes through two hours. At two hours after taking the medication, 7 out of 10 patients taking AVP-825 reported that they were experiencing meaningful relief from their migraine headache. In this study there were no serious adverse events associated with AVP-825.
Presentation Details: Title: Efficacy and Safety of AVP-825, a Novel Breath-Powered™ Powder Sumatriptan Intranasal Treatment, for Acute Migraine Abstract Number: P7.203 Data Blitz Session: I9: INS Data Blitz: Emerging Concepts in Headache Therapy Data Blitz Time: Thursday, May 1 at 4:35 p.m. ET Poster Session: P7: Poster Session VII: Headache: Treatment Poster Time: Thursday, May 1 from 3-6:30 p.m. ET
About AVP-825 AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel Breath Powered delivery technology. If approved, AVP-825 would be the first and only fast-acting, dry-powder intranasal form of sumatriptan for the treatment of migraine. AVP-825 is an investigational drug-device combination product not approved by the FDA. In the phase III clinical trial the most common AEs (incidence >5%) reported for AVP-825 were product taste (22%), nasal discomfort (13%), and rhinitis (6%); local AEs were almost exclusively mild to moderate in severity and transient. Sumatriptan is contraindicated for certain patients, including those with a history of coronary artery disease (CAD) or coronary vasospasm.
The Breath Powered delivery technology is activated by user's breath to propel medications deep into the nasal cavity where absorption is more efficient and consistent than through most other routes. A user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity completely. Through a sealing nosepiece placed into the nostril, the exhaled breath carries medication from the device directly into one side of the nose. Narrow nasal passages are gently expanded and medication is dispersed deep into the nasal cavity reaching areas where it can be rapidly absorbed. As the medication is delivered, the air flows around to the opposite side of the nasal cavity and exits through the other nostril. Closure of the soft palate helps prevent swallowing or inhalation of sumatriptan powder into the lungs.
About NUEDEXTA NUEDEXTA is an innovative combination of two well-characterized components; dextromethorphan hydrobromide (20 mg), the ingredient active in the central nervous system, and quinidine sulfate (10 mg), a metabolic inhibitor enabling therapeutic dextromethorphan concentrations. NUEDEXTA acts on four key receptors in the brain including sigma-1 and NMDA, although the mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown.
NUEDEXTA Important Safety Information NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurological conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state.
Studies to support the effectiveness of NUEDEXTA were performed in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). NUEDEXTA has not been shown to be safe and effective in other types of emotional lability that can commonly occur, for example, in Alzheimer's disease and other dementias.
NUEDEXTA and certain other medicines can interact, causing serious side effects. If you take certain drugs or have certain heart problems, NUEDEXTA may not be right for you.
NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in patients at risk for QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation should be conducted at baseline and 3-4 hours after the first dose.
The most common adverse reactions are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema, urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence. NUEDEXTA may cause dizziness.
These are not all the risks from use of NUEDEXTA. Please refer to full Prescribing Information at www.NUEDEXTA.com.
About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit www.avanir.com.
AVANIR® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries. All other trademarks are the property of their respective owners.
Avanir Pharmaceuticals, Inc. licensed exclusive rights for the development and commercialization of AVP-825, a novel Breath Powered intranasal system containing a low-dose sumatriptan powder from OptiNose Inc. of Yardley, PA.
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Avanir's plans, potential opportunities, or other expectations, product pipeline, product development, clinical studies, the potential benefits of its commercialized products and products under development, projections, goals objectives, milestones, strategies, market growth, and timelines are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with, the market demand for and acceptance of Avanir's products domestically and internationally, research, development and commercialization of new products domestically and internationally, including the risks and uncertainties associated with the NDA acceptance for AVP-825, including, but not limited to, risks relating to the successful development of this investigational drug-device product, delays or failures in obtaining FDA approval, obtaining additional indications for commercially marketed products domestically and internationally, obtaining and maintaining regulatory approvals domestically and internationally, and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
Avanir Investor & Media Contact Ian Clements, PhD [email protected] +1 (949) 389-6700