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Lee Samaha, The Motley Fool
Tue, Apr 1, 2025, 10:23 AM 2 min read
In This Article:
Shares of biopharmaceutical institution Axsome Therapeutics (NASDAQ: AXSM) had declined 6% astatine 11 a.m. ET today. The slump comes aft the institution announced the results of a signifier 3 proceedings of solriamfetol (brand sanction Sunosi) successful large depressive upset (MDD).
The proceedings was somewhat complicated, truthful carnivore with me. It was a six-week proof-of-concept signifier 3 proceedings for MDD "with and without terrible excess daytime sleepiness (EDS)."
The superior purpose of the proceedings was to show important betterment successful the wide colonisation (consisting of 51 patients with terrible EDS and 295 without terrible EDS) utilizing solriamfetol. The grade of severity of EDS was assessed with the Epworth Sleepiness Scale (ESS), and the proceedings utilized the Montgomery-Asberg Depression Rating Scale (MADRS).
The details:
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The proceedings did not show a statistical betterment successful the wide colonisation erstwhile comparing patients connected solriamfetol to those connected a placebo.
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In the MDD patients with terrible EDS, the usage of solriamfetol "resulted successful clinically meaningful and numerically greater improvements compared to placebo connected aggregate efficacy measures including MADRS full score" according to the press release.
The 2nd constituent encouraged the pharmaceutical company's absorption capable to punctual a signifier 3 proceedings successful MDD patients with EDS successful 2025.
It's mixed news. The proof-of-concept proceedings did not conscionable its superior aim, and that's capable to instrumentality the banal lower. Still, there's information to bespeak a affirmative effect successful terrible EDS cases. If those results are replicated successful the forthcoming signifier 3 trial, Axsome tin assertion success, but if solriamfetol is approved lone for usage successful terrible EDS, it volition mean less income than if the cause is approved for the full colonisation of EDS patients.
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