ROX-828

**ROX-828** is an investigational intranasal ketorolac tromethamine formulation developed by ROXRO Pharma for the acute treatment of migraine with and without aura. Each 200 µL dose delivered 31.5 mg ketorolac tromethamine and contained 6% lidocaine. Ketorolac is a nonsteroidal anti-inflammatory drug that nonselectively and reversibly inhibits cyclooxygenase-1 and cyclooxygenase-2, reducing prostaglandin synthesis and providing analgesic and anti-inflammatory activity. The nasal-spray formulation was intended to provide rapid systemic exposure while avoiding gastrointestinal administration in patients whose migraine attacks include nausea or vomiting. In a Phase II placebo-controlled study, ROX-828 improved several pain-relief, pain-free, global-efficacy, and associated-symptom measures versus placebo, although the prespecified two-hour pain-free primary endpoint was not met.