Avanir Pharmaceuticals, Inc.’s (AVNR) Nuedexta (AVP-923) was launched in the U.S. in Feb 2011 for the treatment of pseudobulbar affect (PBA). Net Nuedexta revenues grew 15.2% sequentially to $19 million in the third quarter of fiscal 2013 (ended Jun 30, 2013).
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 comprehensive data from phase III studies of Nuedexta in patients with PBA, plus data from longer-term safety studies.
Avanir is looking to expand the label of Nuedexta into additional indications. Earlier in the month, Avanir announced the commencement of enrollment in a phase II proof-of-concept study (AVR-133) on Nuedexta for the treatment of levodopa induced dyskinesia (:LID) in patients suffering from Parkinson's disease (:PD).
AVR-133 – a double-blind, randomized, crossover study – will compare Nuedexta with placebo for the treatment of LID. The study will enroll 16 PD patients. The patients will be treated with Nuedexta and placebo for 14 days each separated by 2 weeks. Avanir expects to report top-line data from AVR-133 in the second half of calendar 2014.
This drug is being studied for two other indications, namely, agitation in Alzheimer's disease (phase II), and central neuropathic pain in multiple sclerosis (phase II).
The PRIME study is conducted to evaluate the efficacy of Nuedexta for the treatment of central neuropathic pain in multiple sclerosis. Avanir expects to report top-line data from the study by year end.
Avanir currently carries a Zacks Rank #3 (Hold). Currently, companies like Roche (RHHBY), Isis Pharmaceuticals, Inc. (ISIS) and Actelion Ltd. (ALIOF) look more attractive with a Zacks Rank #1 (Strong Buy).