Avanir Pharmaceuticals, Inc. recently held a pre-IND (Investigational New Drug) meeting with the US Food and Drug Administration (FDA) for its next-generation candidate, AVP-786. Following interactions with the FDA, an agreement was reached for a faster development path for Avanir’s AVP-786.
AVP-786, which contains deuterium-modified dextromethorphan and quinidine, is being developed for the treatment of neurologic and psychiatric disorders.
Under the agreement with the FDA, Avanir will be allowed to use the data generated on Nuedexta (AVP-923) 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.
We note that Nuedexta is approved in the US for the treatment of pseudobulbar affect and is under review in the EU.
In Feb 2013, Avanir had completed the first of a two-stage pharmacokinetic study with AVP-786. The study evaluated the candidate’s pharmacokinetics across single and multiple doses. The study identified a formulation of AVP-786 with a comparable pharmacokinetic, safety and tolerability profile to Nuedexta. AVP-786 contains quinidine at a lower dosage than that used in Nuedexta.
Avanir intends to integrate AVP-786 into its ongoing programs on Nuedexta. 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 (neuropathic pain related to multiple sclerosis) being conducted with Nuedexta. Top-line data from the study is expected in the fourth quarter of 2013.
Avanir currently carries a Zacks Rank #3 (Hold). Currently, companies like Santarus, Inc. , Jazz Pharmaceuticals (JAZZ - Free Report) and Salix Pharmaceuticals Ltd. look well positioned with a Zacks Rank #1 (Strong Buy).