The marketing application was based on controlled phase III studies of Nuedexta in patients with PBA, plus data from longer-term safety studies. The EU approval was expected as, in Apr 2013, Avanir had received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Nuedexta.
We note that Nuedexta was launched in the US in Jan 2011 for the treatment of PBA. Net Nuedexta revenues grew 11% sequentially to $16.5 million in the second quarter of fiscal 2013.
We are encouraged by Avanir’s progress on its pipeline. Nuedexta is being studied for three additional indications, namely, agitation in Alzheimer's disease (phase II ongoing), central neuropathic pain in multiple sclerosis (phase II ongoing) and levodopa-induced-dyskinesia in Parkinson's disease (enrollment for phase II about to begin). Avanir plans to accelerate the PRIME study on Nuedexta for the neuropathic pain related to multiple sclerosis indication. Top-line data from the study is expected in the fourth quarter of 2013.
Earlier this month, Avanir had held a pre-IND (Investigational New Drug) meeting with the US Food and Drug Administration (:FDA) for AVP-786. AVP-786 is being developed for the treatment of neurologic and psychiatric disorders. Following interactions with the FDA, an agreement was reached for a faster development path for Avanir’s AVP-786.
Under the agreement with the FDA, Avanir will be allowed to use the data generated on Nuedexta to support the IND application as well as regulatory filings for AVP-786 in the US. This will not only help fasten the development process for AVP-786, it will also lower development-related costs.
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).
More From Zacks.com