Avanir Pharmaceuticals, Inc. recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Nuedexta.
Nuedexta is under review in the EU for the treatment of patients suffering from pseudobulbar affect (PBA). The committee has also recommended approval for two dosage strengths - 20/10 mg and 30/10 mg capsules.
In Nov 2011, Avanir’s Marketing Authorization Application (MAA) for Nuedexta was accepted by the European Medicines Agency (EMA). The application was based on controlled phase III studies of Nuedexta in patients with PBA, plus data from longer-term safety studies.
We note that Nuedexta is approved in the US where it is the first and only Food and Drug Administration (FDA)-approved treatment for PBA. Nuedexta was launched in the US in Jan 2011. Net Nuedexta revenues grew 20% sequentially to $14.9 million in the first quarter of 2013 ending on Dec 2012.
With the CHMP issuing a positive opinion, we expect Nuedexta to gain EU approval shortly.
We are encouraged by Avanir’s progress with its pipeline. In Feb 2013, Avanir completed the first of a two-stage pharmacokinetic study with AVP-786. The study assessed the candidate’s single and multiple dose pharmacokinetics.
Meanwhile, AVP-923 is being studied for four indications, namely, agitation in Alzheimer's disease (phase II ongoing), central neuropathic pain in multiple sclerosis (phase II ongoing), diabetic peripheral neuropathic pain (phase III completed) and levodopa-induced-dyskinesia in Parkinson's disease.
Avanir currently carries a Zacks Rank #4 (Sell). Companies like UCB and Catalyst Pharmaceutical Partners Inc. (CPRX - Free Report) carry a Zacks Rank #1 (Strong Buy). Onyx Pharmaceuticals, Inc. is also well positioned with Zacks Rank #2 (Buy).