FDA Greenlights Phase 3 Study of Rofecoxib for Acute Treatment of Migraine 

The FDA has okayed the initiation of a phase 3 clinical trial to expand development of rofecoxib (TRM-201; Tremeau Pharmaceuticals, Concord, MA), for acute treatment of migraine. Previously marketed as Vioxx, and voluntarily taken off the market because of potential cardiovascular side effects, rofecoxib is now considered an investigational nonopioid treatment. 

Rofecoxib is a cyclooxygenase-2 (COX-2) selective non-steroidal anti-inflammatory drug (NSAID) with an established efficacy profile in multiple indications, including acute treatment of migraine. Rofecoxib has been shown to cross the blood-brain barrier and to have no effect on platelet aggregation, even at supratherapeutic doses.

“Many patients with migraine use an NSAID for rapid relief,” said Charles Argoff, MD, neurologist, Albany Medical Center. “A treatment option such as rofecoxib, with demonstrated once-daily efficacy, a rapid onset of action, no effect on platelet aggregation, and reduced risk of gastrointestinal adverse effects, could be valuable in the treatment of migraine and uniquely suited to meet the needs of the large number of patients who suffer from migraine and cannot tolerate or do not respond to traditional NSAIDs.”
 
The oral tablet formulation of rofecoxib has been shown to reach maximum plasma concentrations (median T_max) at 2 hours after dosing (versus 3 hours for historical Vioxx), which the manufacturer believes could lead to faster onset of action, a critical attribute for migraine.