Axsome's Solriamfetol Fails Primary Goal In Depression Study But Shows Improvements In Associated Sleep Disorder

Axsome Therapeutics, Inc. AXSM on Tuesday released results of the PARADIGM Phase 3 proof-of-concept trial of solriamfetol in major depressive disorder (MDD) with and without severe excessive daytime sleepiness (EDS).

In the overall patient population, the study did not demonstrate a statistically significant change on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to placebo, the study’s primary endpoint.

In the prespecified subgroup of patients with severe EDS, treatment with solriamfetol resulted in greater improvements in depressive symptoms compared to placebo.

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The study was not powered to demonstrate statistical significance in the prespecified subgroups.

Based on the results in the EDS subgroup, Axsome plans to initiate a Phase 3 trial in MDD patients with EDS in 2025.

Solriamfetol was safe and well-tolerated in the trial, with a side effect profile consistent with the established safety profile.

William Blair notes that Axsome already sells Auvelity for MDD.

To prevent competition between its drugs, the company had planned to market solriamfetol specifically to MDD patients who also experience EDS, a common issue in MDD.

Because of this strategy, the limited efficacy signal in the EDS subgroup is not seen as a drawback for the drug's commercial potential.

While the positive results in MDD patients with severe EDS are promising and align with solriamfetol's known effects—it is already sold as Sunosi for EDS linked to obstructive sleep apnea—the PARADIGM study only included a small group of 51 patients.

Larger Phase 3 studies will be needed to confirm these findings.

Analyst Myles Minter writes, “Axsome remains our top pick for 2025. With focus for the company on Auvelity in MDD and an sNDA filing for Alzheimer's disease agitation (AD-A), we believe investor expectations were low for the PARADIGM study, and expect few had factored the opportunity into their valuations.”

Price Action: AXSM stock is down 4.41% at $111.49 at the last check Tuesday.

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