Axsome Therapeutics Announces FDA Approval of AXS-07 (meloxicam and rizatriptan)

This article is notice of a new approval, not intended to be an endorsement of a particular product and/or treatment modality. The American Headache Society® is invested in keeping members informed about the latest updates in headache medicine.  

Thursday, January 30, 2025

Axsome Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has approved AXS-07 (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. This novel oral medication combines meloxicam, a nonsteroidal anti-inflammatory drug, and rizatriptan, a serotonin receptor agonist, to provide rapid and sustained relief from migraine pain. Clinical trials have demonstrated that SYMBRAVO® can lead to pain freedom and a return to normal functioning within two hours of a single dose, with effects lasting up to 48 hours for some patients. The company anticipates that SYMBRAVO will be commercially available in the United States within approximately four months.

The FDA's approval is based on positive results from multiple Phase 3 clinical trials, including the MOMENTUM and INTERCEPT studies. In these trials, SYMBRAVO demonstrated a statistically significant greater percentage of patients achieving pain freedom and freedom from their most bothersome symptom (such as sensitivity to light, sound, or nausea) two hours after dosing compared to placebo. Notably, 77% and 85% of patients treated with SYMBRAVO did not require rescue medication within 24 hours post-dose in the MOMENTUM and INTERCEPT trials, respectively.

Medical experts have highlighted the significance of this approval. Dr. Richard B. Lipton, Professor of Neurology and Director of the Montefiore Headache Center, noted that SYMBRAVO provides rapid and long-lasting relief from migraine pain, whether taken early in the attack or later when the pain is severe. Dr. Stewart Tepper, Clinical Professor of Neurology at the Geisel School of Medicine at Dartmouth, emphasized that SYMBRAVO's multi-mechanistic design addresses key unmet needs in migraine treatment, offering a new, meaningful option for patients.

The migraine community has also welcomed the approval. Susan Doughty, Executive Director of the Coalition for Headache and Migraine Patients (CHAMP), stated that SYMBRAVO offers a new option for people seeking relief and represents an important step forward in addressing the needs of those living with this often misunderstood and stigmatized neurological disease.

Source: Axsome Therapeutics