SK biopharmaceuticals’ sleep disorder treatment solriamfetol (Sunosi in the U.S. trademark) failed to meet its primary endpoint in a phase 3 clinical trial led by Axsome Therapeutics in the U.S. for patients with major depressive disorder (MDD).
On Tuesday (local time), Axsome Therapeutics released top-line data from the phase 3 PARADIGM study evaluating solriamfetol for major depressive disorder.
(Credit: Getty Images)
(Credit: Getty Images)
The PARADIGM study, a proof-of-concept study to explore the potential for a new indication for solriamfetol, divided MDD patients into two groups based on the presence or absence of severe excessive daytime sleepiness (EDS) and treated them with either 300 mg of solriamfetol or placebo for six weeks.
Daytime sleepiness was measured using the Epworth Sleepiness Scale (ESS), with an ESS score of 16 or higher defined as severe EDS.
The study's primary endpoint was a change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score, but an analysis of the overall patient population (n=346) showed no statistically significant improvement over placebo.
However, in a predefined subgroup analysis, patients with severe EDS (n=51) demonstrated numerical improvements over placebo in several endpoints, including MADRS scores, dysphoria scale, remission rate, CGI-S, CGI-I, and PGI-I.
Based on these results, Axsome Therapeutics plans to initiate a separate phase 3 clinical trial in MDD patients with EDS in 2025. Detailed results from the PARADIGM study will be presented at upcoming scientific meetings.
EDS is a comorbid symptom that affects about 50 percent of people with MDD and has a significant impact on daily functioning and safety due to difficulty maintaining wakefulness. No medications have been approved for treating MDD patients with EDS.
“The PARADIGM study confirms the therapeutic potential of solriamfetol in MDD patients with EDS,” said Herriot Tabuteau, CEO of Axsome Therapeutics. “The significant results in this patient population are consistent with the drug's mechanism of action and support the potential for new indications in the future.”
Solriamfetol is a sleep disorder treatment developed and exported by SK biopharmaceuticals and is being developed for treating attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD), binge eating disorder (BED), and shift work sleep disorder (SWD) in addition to narcolepsy.
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Kim Chan-hyuk kch@docdocdoc.co.kr
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