ALISO VIEJO, Calif., June 25, 2013 /PRNewswire/ --Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the European Commission has approved NUEDEXTA (dextromethorphan hydrobromide/quinidine sulfate) in the European Union for the treatment of pseudobulbar affect (PBA), irrespective of underlying neurologic disease or injury. ?
"The approval of NUEDEXTA by the European Commission is a major breakthrough for people with PBA who, until now, have had no EMA approved medications indicated to treat this debilitating disorder," said Joao Siffert, MD, chief scientific officer at Avanir. "NUEDEXTA addresses a genuine unmet patient need and demonstrates Avanir's commitment to bringing innovative treatments to people in Europe and throughout the world."
PBA is a neurologic condition characterized by outbursts of uncontrollable crying or laughing that are often contrary or exaggerated to the patient's inner mood state. As a result, many of those afflicted with PBA show significant impairment on standard measures of health status, and disruption in occupational and social function, often leading to social isolation. PBA occurs secondary to a variety of neurologic conditions such as traumatic brain injury, multiple sclerosis, amyotrophic lateral sclerosis (Lou Gehrig's disease), Parkinson's disease, stroke and Alzheimer's disease. When these disorders damage areas of the brain that regulate normal emotional expression, they can lead to uncontrollable, disruptive episodes of crying or laughing.
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 wit
JMP: Raising Nuedexta Sales Estimates on Strong F3Q13 Prescription Data
July 8, 2013
Increasing FY13 sales estimates based on strong prescription growth in F3Q13;
reiterate Market Outperform rating and $7 price target on Avanir Pharmaceuticals.
According to data from IMS Health, Nuedexta achieved strong sequential volume
growth of ~24% in F3Q13. This represents a meaningful acceleration from the Q/Q
growth reported in F2Q13 (~11%) and ahead of our expectations for F3Q13 growth
of 11%. Based on our analysis of these data, we are increasing our F3Q13 total
revenue estimate by ~10%, from $18.9MM to $20.7MM (vs. consensus of $19.3MM).
Sentiment: Strong Buy