Avanir Pharmaceuticals announces positive interim data from study with AVP-786 Avanir Pharmaceuticals announced 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. The company has requested a meeting with the FDA to discuss the full development path for AVP-786. 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. As a result of this change, the company now expects to have data from the PRIME study in the fourth calendar quarter of 2013.
Avanir's AVP-825 device for migraine shows positive results Avanir's COMPASS Phase IIIb, cross-over clinical trial comparing the efficacy and safety of AVP-825 22mg to sumatriptan 100mg tablets for the treatment of acute migraine across multiple attacks, showed that patients treated with AVP-825 achieved pain relief and pain freedom in significantly more migraine attacks at all time points from 15-90 minutes post-dose compared to sumatriptan tablets. A New Drug Application for AVP-825 has been accepted and is currently under review by the FDA with a Prescription Drug User Fee Act goal date of November 6.