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Avanir Pharmaceuticals Announces Positive Interim Data From Pharmacokinetic Study With Next Generation Compound AVP-786
Date:2/7/2013

ALISO VIEJO, Calif., Feb. 7, 2013 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced today that it has successfully completed the first of a two-stage pharmacokinetic study with AVP-786, a drug product containing a deuterium modified form of dextromethorphan. Based on interim data, Avanir believes that it has identified a formulation of AVP-786 with a comparable pharmacokinetic, safety and tolerability profile to AVP-923 (dextromethorphan hydrobromide and quinidine sulfate).  The company has requested a meeting with the FDA to discuss the full development path for AVP-786.

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"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."

Avanir also announced today that the company intends to modify the enrollment target of its ongoing phase II clinical study of AVP-923 in central neuropathic pain in multiple sclerosis to 200 patients. 

"With the encouraging pharmacokinetic results in hand, we have made the decision to accelerate the completion of the PRIME study, as we believe AVP-786 has the potential to be a preferable development compound," said Joao Siffert , MD. "We plan to use the data from the PRIME study to guide the further development of AVP-786."

As a result of this change, the company now expects to have data from the PRIME study in the fourth calendar quarter of 2013
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SOURCE Avanir Pharmaceuticals, Inc.
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