ALISO VIEJO, Calif.
Sept. 6, 2013
Avanir Pharmaceuticals, Inc.
(NASDAQ: AVNR) today announced that it has entered into a settlement agreement with Wockhardt
, LLC and Wockhardt Ltd. (collectively, "Wockhardt") to resolve pending patent litigation in response to Wockhardt's abbreviated new drug application (ANDA) seeking approval to market generic versions of Avanir's NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) capsules.
The settlement agreement grants Wockhardt the right to begin selling a generic version of NUEDEXTA on
July 30, 2026
, or earlier under certain circumstances. The parties have also agreed to file a stipulation and order of dismissal with the United States District Court for the District of
which will conclude this litigation with respect to Wockhardt. The settlement does not end Avanir's ongoing litigation against the other two ANDA filers.
In compliance with U.S. law, the settlement agreement will be submitted to the U.S. Federal Trade Commission and the Department of Justice where it is subject to review.
NUEDEXTA is an innovative combination of two well-characterized components; dextromethorphan hydrobromide, the ingredient active in the central nervous system, and quinidine sulfate, 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 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.