AVANIR Pharmaceuticals Announces U.S. Launch and Availability of NUEDEXTA™ for Pseudobulbar Affect
ALISO VIEJO, Calif., Jan. 31, 2011 /PRNewswire/ -- AVANIR Pharmaceuticals, Inc. (Nasdaq: AVNR) today announced that NUEDEXTA™ (dextromethorphan hydrobromide and quinidine sulfate) is now available by prescription in the United States. NUEDEXTA is the first and only treatment approved by the U.S. Food and Drug Administration (FDA) for pseudobulbar affect (PBA). PBA is a neurologic condition causing involuntary, sudden and frequent episodes of laughing and crying in patients with certain underlying neurologic diseases or injuries. PBA episodes typically occur out of proportion or incongruent to the patient's underlying emotional state.
"We are very pleased to announce that NUEDEXTA is now available for prescription through retail pharmacies across the country," said Keith Katkin, AVANIR's President and CEO. "After years of hard work and perseverance, the availability of NUEDEXTA is an important milestone for the many patients in the United States suffering from PBA who now have access to a safe, effective treatment."
"It's promising to see new therapies like NUEDEXTA coming on to the market, providing patients with additional tools to help manage some of the disabling conditions associated with brain injuries and other neurologic conditions," said Susan H. Connors, President and Chief Executive Officer of the Brain Injury Association of America. "We look forward to seeing more trends like this emerge."
In conjunction with its availability in pharmacies nationwide, AVANIR's sales force will commence promotion on February 7, 2011 to neurologists, psychiatrists and other physicians who treat patients with PBA secondary to underlying neurologic conditions such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) , traumatic brain injury (TBI), stroke, Parkinson's disease and certain other neurologic diseases.
The national launch of NUEDEXTA is being supported by 75 specialty sales representatives, the majority of whom have significant prior experience selling CNS therapies to the neurology and psychiatry audiences. Additionally, the Company has built a managed markets account team that is now interfacing with formulary decision makers from key Medicare Part D plans, commercial insurers, pharmacy benefit managers and drug wholesalers to maximize patient access to NUEDEXTA.
To support the availability of NUEDEXTA for all patients with PBA, AVANIR has initiated several patient support services such as a reimbursement counseling hotline and a co-pay assistance program. These NUEDEXTA patient support services are intended to help people who suffer from PBA navigate potential administrative insurance issues as well as to reduce out-of-pocket costs for eligible patients. For more information about NUEDEXTA and the patient support services, please visit NUEDEXTA.com or call 855-4NUEDEX (468-3339).
NUEDEXTA™ is the first and only FDA-approved treatment for pseudobulbar affect (PBA). 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 sigma-1 and NMDA receptors in the brain, although the mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown.
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 patient's 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. The primary outcome measure, laughing and crying episodes, was significantly lower in the NUEDEXTA arm compared to placebo. The secondary outcome measure, the Center for Neurologic Studies Lability Scale (CNS-LS), demonstrated a significantly greater mean decrease in CNS-LS score from baseline for the NUEDEXTA arm compared to placebo.
NUEDEXTA Important Safety Information
NUEDEXTA can interact with other medications causing significant changes in blood levels of those medications and/or NUEDEXTA. NUEDEXTA is contraindicated in patients receiving drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine and pimozide) and should not be used concomitantly with other drugs containing quinidine, quinine, or mefloquine. NUEDEXTA is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs within the preceding 14 days. NUEDEXTA is contraindicated in patients with a known hypersensitivity to its components.
NUEDEXTA may cause serious side effects, including possible changes in heart rhythm. NUEDEXTA is contraindicated in patients with a prolonged QT interval, congenital long QT syndrome or a history suggestive of torsades de pointes, in patients with heart failure as well as patients with, or at risk of, complete atrioventricular (AV) block, unless the patient has an implanted pacemaker.
NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in patients at risk of QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation of QT interval should be conducted at baseline and 3-4 hours after the first dose.
The most common adverse reactions in patients taking NUEDEXTA are diarrhea, dizziness, cough, vomiting, weakness, swelling of feet and ankles, urinary tract infection, flu, elevated liver enzymes, and flatulence.
NUEDEXTA may cause dizziness. Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls.
Patients should take NUEDEXTA exactly as prescribed. Patients should not take more than 2 capsules in a 24- hour period, make sure that there is an approximate 12-hour interval between doses, and not take a double dose after they miss a dose.
These are not all the risks from use of NUEDEXTA. For additional important safety information about NUEDEXTA, please see the full Prescribing Information at www.NUEDEXTA.com.
Patients suffering from existing neurological disease or brain injury may also suffer the added burden of pseudobulbar affect, or 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 patient's underlying emotional state. PBA outbursts result from a "short circuit" in the brain caused by another neurologic condition-such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), stroke, or traumatic brain injury. PBA can have a debilitating impact on the lives of patients, caregivers and loved ones. For more information about PBA, please visit www.PBAinfo.org.
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.
About Forward-Looking Statements
Statements in this press release that are not historical facts, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project," or similar statements, may be forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from the future results expressed or implied by such statements. These statements include, but are not limited to, the safety and efficacy of NUEDEXTA. Risks that could cause actual results to differ include the occurrence of adverse safety events with NUEDEXTA, that NUEDEXTA may not gain acceptance by the medical field, our dependence on third parties for manufacturing and distribution of NUEDEXTA, that we may not adequately build or maintain the necessary sales, marketing, supply chain management and reimbursement capabilities on our own or enter into arrangements with third parties to perform these functions in a timely manner or on acceptable terms, and other risks that are described in further detail in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and from time-to time in other publicly available information regarding the Company. Copies of this information are available from us upon request. We disclaim any intent to update these forward-looking statements.
AVANIR™ and NUEDEXTA™ are trademarks owned by AVANIR Pharmaceuticals, Inc.
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SOURCE AVANIR Pharmaceuticals, Inc.
Jan 31, 2011