Hmmm....may not be great news for POZN, which I still own...competition for their migraine drug Treximet...which has a huge head start, has been on sale for years, recently sold the rights to Pernix for royalties of $4M+ per quarter through 2018.
But this is confusing - AVNR file the NDA *before* they completed the COMPASS trial? How's that work?
ALISO VIEJO, Calif., June 10, 2014 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (AVNR) today announced that COMPASS, its Phase IIIb clinical trial comparing the efficacy and safety of the investigational product AVP-825 22mg to sumatriptan 100mg tablets for the treatment of acute migraines in adults, met the primary efficacy endpoint. AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel Breath Powered™ delivery technology. In March 2014, the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) of AVP-825 and the Prescription Drug User Fee Act (PDUFA) V goal date is November 26, 2014.
The Thought Police: To censor and protect. Craig Bruce
