Avanir Pharmaceuticals, Inc. announced that it has filed lawsuits in the US District Court for the District of Delaware against Par Pharmaceutical, Inc. and Par Pharmaceutical Companies, Inc (collectively "Par") and Actavis South Atlantic LLC and Actavis, Inc. (collectively "Actavis").

The lawsuits were filed in response to Abbreviated New Drug Applications ("ANDAs") filed by Par and Actavis. In their applications, Par and Actavis seek to market and sell generic versions of the currently approved dose of Nuedexta prior to the expiration of US patents 7,659,282 and RE38,115 (which are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations ("Orange Book")). Avanir filed the lawsuits on the basis that Par's and Actavis' proposed generic products infringe certain patents held by Avanir.

In accordance with the Hatch-Waxman Act, as a result of having filed lawsuits within 45 days of the Paragraph IV certification notices, FDA approval of the ANDAs will be stayed until the earlier of (i) 30 months from the Company's receipt of the notices or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or not infringed.

Avanir intends to vigorously enforce its patent rights.

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.

Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need.