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2/7/2013 9:57:16 AM
LEXINGTON, Mass.--(BUSINESS WIRE)--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.”
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