Groundbreaking Drug Launches
Meloxicam/rizatriptan (SYMBRAVO)
Mechanism of Action: Cyclo-oxygenase 2 inhibitors; Serotonin 1B receptor agonists; Serotonin 1D receptor agonists Drug class: Small molecules Originator: Axsome Therapeutics Indication: Migraine Approval date: 31 January, 2025 Trials: MOMENTUM and INTERCEPT
Migraine
Migraine is more than just a severe headache. Symptoms vary but often include recurring headaches, nausea, vomiting, fatigue, and sensitivity to light, noise, and smells. These symptoms can occur during or between migraine attacks, which may last from hours to days and interfere with daily activities. A common symptom is throbbing pain, usually on one side of the head, caused by abnormal nerve, chemical, and blood vessel activity in the brain. Some people experience migraines at predictable times, like before their period or after a stressful week. Between attacks, individuals may also struggle with concentration, depression, anxiety, fatigue, sleep issues, and chills.
Prevalence
The prevalence of migraine varies by region and gender, with an estimated global rate of 11% to 15%. In the United States: • Migraine prevalence has remained stable over the past 30 years, ranging from 11.7% to 14.7%. • Women are more likely to experience migraines than men. • The highest prevalence is among American Indian or Alaska Native populations, and the lowest is among Asians. Globally: • The global age-standardized prevalence of migraine is estimated at 14.4%. • Women are more affected than men. • The highest incidence occurs in the 10–14-year age group. Other factors: • Migraine is more common in middle-aged individuals and less so in adolescents and those over 60. • It is often a lifelong condition with recurring episodes. • Triggers for migraine attacks include alcohol and certain foods.
Treatment
Migraines can be treated with various medications, including over-the-counter pain relievers, triptans, and CGRP antagonists. The best treatment depends on the severity of symptoms and other factors.
Over-the-counter pain relievers: • Ibuprofen: An NSAID effective for mild to moderate migraines • Aspirin: A pain reliever for mild to moderate migraines • Acetaminophen: A pain reliever for mild to moderate migraines
Triptans: • Sumatriptan: A common treatment that increases serotonin levels in the brain • Zolmitriptan: A treatment that raises serotonin levels • Naratriptan: A non-hormonal tablet for migraine relief • Frovatriptan: A non-hormonal tablet for migraine relief
CGRP antagonists: • Atogepant: Used for short or long-term migraine treatment Other treatments: • Nausea relief drugs: Help manage queasiness • Ergot derivative drugs: Effective during early stages of a migraine • Noninvasive neuromodulation devices: An option for those who don't respond to or tolerate medications
Why is Meloxicam/rizatriptan poised to make an impact in 2025?
On September 4, 2024, Axsome Therapeutics announced that the FDA has accepted its resubmitted New Drug Application (NDA) for Meloxicam/rizatriptan, a novel treatment for acute migraine. Meloxicam/rizatriptan combines meloxicam and rizatriptan, leveraging Axsome's MoSEIC technology to enable rapid absorption and extended plasma half-life. This submission follows a complete response letter from May 2022, which addressed manufacturing concerns but did not require additional clinical trials. The NDA is backed by positive data from the MOMENTUM and INTERCEPT Phase 3 trials, which showed Meloxicam/rizatriptan’s superiority over placebo in achieving pain freedom and reducing the most bothersome migraine symptoms.
“Axsome Therapeutics believes, if approved, AXS-07 could reach peak sales of $500 million to $1.0 billion.”
Regulatory milestones
Registrational Trials
The U.S. Food and Drug Administration (FDA) has approved Meloxicam/rizatriptan for the acute treatment of migraine with or without aura in adults based on the efficacy and safety data of MOMENTUM and INTERCEPT trials.
MOMENTUM:
A Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of Meloxicam/rizatriptan (AXS-07) for the Acute Treatment of Migraine in Adults (NCT03896009).
INTERCEPT
A phase 3 clinical trial aimed to evaluate the efficacy and safety of Meloxicam/rizatriptan (AXS-07), an investigational oral medication combining meloxicam and rizatriptan, for the acute treatment of migraines in adults (NCT04163185).
“Meloxicam/rizatriptan showed superiority over placebo in achieving pain freedom and reducing migraine symptoms”