Axsome Therapeutics’ AXSM Auvelity (AXS-05) was launched in the United States in 2022 for the treatment of major depressive disorder (MDD), making it the first approved drug in the company’s portfolio.
Auvelity generated sales worth $291.4 million in 2024, reflecting an increase of 124% year over year in the United States. Sales of the drug are being driven by an increase in unit sales volume and the momentum is likely to continue in 2025.
Axsome is also working to expand the label of Auvelity for the larger commercial opportunity in other central nervous system (CNS) disorders like Alzheimer’s disease (AD) agitation and smoking cessation.
Axsome plans to submit a new drug application (NDA) for AXS-05 in AD agitation to the FDA in the second half of 2025. The company also plans to initiate a phase II/III pivotal study on AXS-05 for smoking cessation later in 2025.
The successful development and potential approval of Auvelity in additional indications will help the drug address a broader patient population and drive sales further.
Axsome acquired U.S. rights to Sunosi, a commercialized drug targeting narcolepsy, from Jazz Pharmaceuticals JAZZ in 2022. It began selling Sunosi in the U.S. market in May 2022 and in certain international markets in November 2022.
Jazz had received approval for Sunosi as a treatment for narcolepsy in 2019.
JAZZ is entitled to receive a high single-digit royalty from Axsome on net sales of Sunosi in the United States. AXSM out-licensed its ex-U.S. marketing rights of Sunosi to Pharmanovia in February 2023.
Sunosi has become an important revenue driver for Axsome since its acquisition from Jazz. The drug generated sales worth $94.3 million in 2024, reflecting an increase of 26% on a year-over-year basis.
Axsome is evaluating Sunosi in separate phase III studies for treating attention deficit hyperactivity disorder (ADHD), MDD, binge eating disorder and excessive sleepiness associated with shift work disorder.
Top-line data from the FOCUS study and the PARADIGM study, evaluating Sunosi for treating ADHD and MDD, respectively, are expected to be released later in the first quarter of 2025.
In January 2025, the FDA approved Axsome’s Symbravo (meloxicam and rizatriptan) or AXS-07 for the acute treatment of migraine with or without aura in adults. The company expects to launch Symbravo in the United States in about four months. The approval has diversified Axsome’s commercial portfolio and should boost the company’s growth prospects.
This apart, Axsome is nearing two potential approvals for its other pipeline candidates. The company plans to submit an NDA to the FDA seeking approval of AXS-14 for the treatment of fibromyalgia later in the first quarter of 2025.
Axsome also plans to submit an NDA for AXS-12 for treating cataplexy in patients with narcolepsy to the FDA in the second half of 2025.
The steady performance of Auvelity and Sunosi, along with the recent drug approval and encouraging pipeline progress, should maintain momentum for Axsome.
Though Axsome is riding on the success of Auvelity and Sunosi, competition looms large in the target market as many companies are developing treatments to address various CNS disorders. One such company is Acadia Pharmaceuticals ACAD, which currently markets its lead drug, Nuplazid (pimavanserin).
ACAD’s Nuplazid is the first and only drug approved by the FDA for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
Acadia is also developing other pipeline candidates targeting various other CNS disorders. Sunosi is also likely to face competition from Jazz’s sleep disorder drugs, which hold a strong market share.
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