Avanir Pharmaceuticals, Inc. (AVNR) recently announced that it has finished enrolling patients in its phase II study, PRIME (Pain Research In Multiple sclErosis), which is being conducted to evaluate the efficacy of Nuedexta for the treatment of central neuropathic pain in multiple sclerosis (MS).
The 12-week, multicenter, randomized, double-blind, placebo-controlled, four-arm parallel group study has enrolled patients who will receive one of three dosage levels of Nuedexta (45/10 mg, 30/10 mg, or 20/10 mg) or placebo.
The primary endpoint of the study is the Numeric Pain Rating Scale (PRSG) obtained from patient diaries. Secondary endpoints of the study include measurement of fatigue, impact of MS on daily life, sleep quality, spasticity, cognition and depression.
Top-line data from the PRIME study is expected in the fourth quarter of calendar 2013.
We note that Nuedexta was launched in the US in Jan 2011 for the treatment of pseudobulbar affect (PBA). Net Nuedexta revenues grew 11% sequentially to $16.5 million in the second quarter of fiscal 2013 (ended Mar 2013).
We are also encouraged by Avanir’s progress on its pipeline. In Jun 2013, Avanir received approval for Nuedexta in the EU for the treatment of patients suffering from PBA. The marketing application was based on controlled phase III studies of Nuedexta in patients with PBA, plus data from longer-term safety studies.
Nuedexta is being studied for two additional indications, namely,agitation in Alzheimer's disease (phase II ongoing), and levodopa-induced-dyskinesia in Parkinson's disease (enrollment for phase II about to begin).
Avanir currently carries a Zacks Rank #3 (Hold). Currently, companies like Santarus, Inc. (SNTS), Jazz Pharmaceuticals Public Limited Company (JAZZ) and Salix Pharmaceuticals Ltd. (SLXP) look well positioned with a Zacks Rank #1 (Strong Buy).
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