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Concert Pharmaceuticals, Inc. today announced that it has achieved a milestone under its licensing agreement with Avanir Pharmaceuticals, Inc. for the development of AVP-786 (also known as CTP-786 or deuterated dextromethorphan). Avanir has successfully completed the first of a two-stage pharmacokinetic study in healthy subjects with AVP-786. The worldwide licensing agreement with Avanir was entered into in 2012.
Based on interim data, Avanir believes that it has identified a formulation of AVP-786 with a comparable pharmacokinetic, safety and tolerability profile to a previously investigated fixed dose combination of dextromethorphan hydrobromide and quinidine sulfate, AVP-923. Avanir has requested a meeting with the FDA to discuss the full development path for AVP-786.
“The results of this study are very encouraging,” said Joao Siffert, MD, chief scientific officer for Avanir. “We were able to successfully replicate the steady-state plasma levels of AVP-923, but with a substantially lower dose of quinidine. Given these results, we believe that AVP-786 would be an ideal candidate to test in one or more of our ongoing clinical programs.”
“We are very pleased with these results and with Avanir’s commitment to this program,” said Roger Tung, Ph.D., President and CEO of Concert Pharmaceuticals.
The exclusive license agreement provides Avanir with worldwide rights to develop and commercialize AVP-786 and other deuterium-modified dextromethorphan (d-DM) compounds that are believed to have potential for the treatment of neurological and psychiatric disorders. Under the agreement, Concert is eligible to receive additional milestone payments upon achievement of certain predefined clinical, regulatory and commercial targets. Avanir will continue to have overall responsibility for research, development and commercialization of d-DM compounds, including AVP-786, and Concert is eligible to receive tiered royalties on worldwide sales of any products containing d-DM.
AVP-786 is a novel compound developed through incorporation of deuterium into specific molecular positions of dextromethorphan. The compound maintains similar pharmacology to that of dextromethorphan, but is less susceptible to metabolism by the CYP2D6 enzyme.