FDA approves NUEDEXTA capsules for pseudobulbar affect

AVANIR Pharmaceuticals, Inc. (Nasdaq: AVNR) today announced that the U.S. Food and Drug Administration (FDA) has approved NUEDEXTA™ (dextromethorphan hydrobromide and quinidine sulfate) capsules, as the first treatment for pseudobulbar affect.  

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.    

"The FDA approval of NUEDEXTA marks an important milestone for people living with PBA, an under-recognized and debilitating neurologic condition," said Keith Katkin, president and chief executive officer of Avanir.  "The approval of NUEDEXTA also marks AVANIR's transition toward becoming a commercial enterprise, ready to support the successful launch of the first FDA-approved treatment for PBA. We expect that NUEDEXTA will be available by prescription during the first quarter of 2011."

"This FDA approval represents a significant step forward for people who live with the debilitating effects of PBA," said Dr. Nicholas LaRocca, Vice President of Healthcare Delivery and Policy Research at the National MS Society. "For people who experience unexplained bouts of inappropriate laughing or crying, this new therapy has the potential to substantially help both them and their families."

"Today's approval of NUEDEXTA is a testament to the conviction of the patients and researchers who participated in our studies and represents over 10 years of research and development by our dedicated employees," said Randall Kaye, MD, Chief Medical Officer, AVANIR Pharmaceuticals. "We are very pleased to bring the first proven treatment option to the many patients in the U.S. living with PBA.  I would like to thank FDA for working closely with us to make NUEDEXTA available."

"PBA is a disabling neurologic condition commonly found in patients with underlying neurologic diseases or injuries. These patients frequently experience embarrassment due to their unpredictable emotional outbursts, leading to disruption of their interpersonal relationships and social isolation," said Erik P. Pioro, MD, PhD, FRCPC, Director of the Section for ALS and Related Disorders at the Cleveland Clinic in Cleveland, Ohio and an investigator in clinical studies evaluating NUEDEXTA. "As a physician who has cared for many patients with PBA, I am pleased that there is now a safe and effective treatment option for PBA that may help these patients regain more control over their daily lives and live with dignity."

NUEDEXTA is a first-in-class medication that acts on sigma-1 and NMDA receptors in the brain, although the exact mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown. 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.