The FDA has approved SYMBRAVO® (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults, marking the first approval of this combination therapy. The oral medication combines meloxicam (20 mg) and rizatriptan (10 mg) using MoSEIC™ (Molecular Solubility Enhanced Inclusion Complex) technology for rapid absorption.

The approval is based on two Phase 3 trials (MOMENTUM and INTERCEPT) and one long-term safety trial (MOVEMENT) encompassing over 21,000 migraine attacks. In the MOMENTUM trial, which evaluated moderate to severe migraine pain, SYMBRAVO demonstrated statistically significant superiority over placebo in achieving pain freedom and relief from most bothersome symptoms (photophobia, phonophobia, nausea) at two hours post-dose. The medication showed superior sustained pain freedom from 2 to 24 hours compared with rizatriptan alone.

The INTERCEPT trial, focusing on treatment at mild pain onset, showed similar superiority over placebo. Across both Phase 3 trials, 85% and 77% of SYMBRAVO-treated patients did not require rescue medication within 24 hours. The MOVEMENT trial evaluated long-term safety in 706 patients treating at least two migraines monthly for up to 12 months.

Common adverse reactions (≥1% and greater than placebo) included somnolence and dizziness, each occurring in 2% of SYMBRAVO patients versus 1% with placebo. SYMBRAVO is contraindicated in patients with cardiovascular conditions including ischemic coronary artery disease, coronary artery vasospasm, and peripheral vascular disease. Additional contraindications include history of stroke or transient ischemic attack, hemiplegic or basilar migraine, and uncontrolled hypertension.

The medication is expected to become commercially available in approximately four months. Efficacy was demonstrated across mild, moderate, and severe migraine pain intensities, with benefits sustained through 24 and 48 hours in some patients.

Source: Axsome