Axsome’s Solriamfetol Fails Main Purpose In Despair Examine However Exhibits Enhancements In Related Sleep Dysfunction – Axsome Therapeutics (NASDAQ:AXSM)

Axsome Therapeutics, Inc. AXSM on Tuesday launched outcomes of the PARADIGM Section 3 proof-of-concept trial of solriamfetol in main depressive dysfunction (MDD) with and with out extreme extreme daytime sleepiness (EDS).

Within the total affected person inhabitants, the examine didn’t reveal a statistically vital change on the Montgomery-Åsberg Despair Ranking Scale (MADRS) whole rating in comparison with placebo, the examine’s major endpoint.

Within the prespecified subgroup of sufferers with extreme EDS, therapy with solriamfetol resulted in higher enhancements in depressive signs in comparison with placebo.

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The examine was not powered to reveal statistical significance within the prespecified subgroups.

Based mostly on the leads to the EDS subgroup, Axsome plans to provoke a Section 3 trial in MDD sufferers with EDS in 2025.

Solriamfetol was protected and well-tolerated within the trial, with a aspect impact profile per the established security profile.

William Blair notes that Axsome already sells Auvelity for MDD.

To stop competitors between its medicine, the corporate had deliberate to market solriamfetol particularly to MDD sufferers who additionally expertise EDS, a standard subject in MDD.

Due to this technique, the restricted efficacy sign within the EDS subgroup will not be seen as a downside for the drug’s business potential.

Whereas the optimistic leads to MDD sufferers with extreme EDS are promising and align with solriamfetol’s identified results—it’s already offered as Sunosi for EDS linked to obstructive sleep apnea—the PARADIGM examine solely included a small group of 51 sufferers.

Bigger Section 3 research will probably be wanted to substantiate these findings.

Analyst Myles Minter writes, “Axsome stays our high decide for 2025. With focus for the corporate on Auvelity in MDD and an sNDA submitting for Alzheimer’s illness agitation (AD-A), we imagine investor expectations have been low for the PARADIGM examine, and count on few had factored the chance into their valuations.”

Value Motion: AXSM inventory is down 4.41% at $111.49 on the final verify Tuesday.

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