While statistics are presumed to provide cold measurement of a clinical study, the final arbiter is the FDA. Thus despite having positive clinical data for a product that is a combination of two widely used drugs, Algos Pharmaceutical Corp. received a non-approvable letter last week for its MorphiDex combination of morphine and dextromethorphan to treat moderate to severe cancer pain.

The clinical data that had been presented on MorphiDex, combined with the fact that both morphine (an opioid analgesic) and dextromethorphan (an NMDA receptor antagonist) are approved drugs, may have suggested that