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Axsome Therapeutics, Inc. AXSM announced that the FDA has approved Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults.
Per the company, Symbravo, a novel, oral medicine, offers a multi-mechanistic approach to treating migraine. It targets multiple pathways underlying a migraine attack.
AXSM expects to launch Symbravo in the United States in about four months.
Shares of AXSM were up 3.5% on Jan. 30 following the news announcement.
The stock has rallied 20.8% in the past year against the industry’s decline of 10.2%.
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More on AXSM's Newest Migraine Drug
The FDA for Symbravo was based on data from a comprehensive clinical program that consisted of multiple phase III studies, the MOMENTUM study, INTERCEPT and the phase III MOVEMENT long-term open-label safety study.
Data from the phase III MOMENTUM and INTERCEPT studies showed that 77% and 85% of patients who were treated with Symbravo did not require rescue medication within 24 hours after the dose, respectively.
Data from both these studies showed that treatment with Symbravo led to a statistically significantly greater percentage of patients achieving pain freedom and freedom from their most bothersome symptom versus placebo, two hours after dosing.
The MOVEMENT study demonstrated the long-term safety of Symbravo in the given patient population.
Also, treatment with Symbravo demonstrated superior efficacy across a broad range of migraine severity (mild, moderate, and severe).
FDA Nod for Symbravo Diversifies AXSM's Product Portfolio
The latest FDA nod for Symbravo diversifies Axsome’s commercial drug portfolio. The company currently markets Auvelity (AXS-05) for treating major depressive disorder (MDD) and Sunosi (solriamfetol) for treating narcolepsy.
Auvelity was launched in the United States in 2022 for the treatment of MDD, making it the first approved drug in the company’s portfolio. The drug generated sales worth $198.8 in the first nine months of 2024, reflecting an increase of 145.4% year over year in the United States.
Axsome’s second marketed drug, Sunosi, is approved for treating narcolepsy. The company acquired U.S. rights to Sunosi from Jazz Pharmaceuticals JAZZ in May 2022. It began selling Sunosi in the U.S. market in May 2022 and in certain international markets in November 2022.
Jazz received approval for Sunosi as a treatment for narcolepsy in 2019.
The acquisition of Sunosi from Jazz diversified Axsome’s portfolio of drugs. In the first nine months of 2024, Sunosi’s net product sales were $65.6 million, reflecting an increase of almost 30% year over year. The drug has become an important revenue driver for Axsome.