Pfizer announced today that it has submitted a new drug application to the Food and Drug Administration for its next-generation migraine prevention therapy, PF-4921, which demonstrated a 62 percent reduction in monthly migraine days during Phase III clinical trials. The oral medication targets a novel receptor pathway not addressed by existing CGRP inhibitors.

The Phase III trial enrolled 4,500 participants with chronic migraine and showed that PF-4921 was well tolerated, with the most common side effects being mild nausea and fatigue. Analysts project that if approved, the drug could capture a significant share of the estimated $8 billion migraine treatment market by offering an alternative mechanism of action for patients who do not respond to current therapies.