Tremeau Receives May Proceed Notification From FDA For Phase III Program in Acute Migraine For TRM-201 (Rofecoxib)
Tremeau Pharmaceuticals today announced it has successfully opened an investigational new drug (IND) application and received a May Proceed Notification from FDA to expand the development program for TRM-201 (rofecoxib), an investigational non-opioid treatment, to include a Phase III program for acute migraine.
- Tremeau Pharmaceuticals today announced it has successfully opened an investigational new drug (IND) application and received a May Proceed Notification from FDA to expand the development program for TRM-201 (rofecoxib), an investigational non-opioid treatment, to include a Phase III program for acute migraine.
- Previously marketed as VIOXX, rofecoxib is a cyclooxygenase-2 (COX-2) selective non-steroidal anti-inflammatory drug (NSAID) with a well-established efficacy profile in multiple indications, including acute migraine.
- Tremeau expects that the development program for TRM-201 will include one Phase III acute efficacy and safety study in migraine.
- Tremeau is a Massachusetts-based pharmaceutical company focused on providing non-opioid pain treatments for well-defined patient populations with significant unmet needs.