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Axsome Plans Excessive Sleepiness Study In Depression After Phase III Failure

 
• By Alaric DeArment

The study’s failure in the overall MDD population was not a surprise, but solriamfetol’s efficacy in MDD with EDS provided a rationale for testing it in that subpopulation.

Depression concept
(Shutterstock)

A week after announcing results for solriamfetol in attention deficit hyperactivity disorder (ADHD) that left some analysts questioning its market differentiation, Axsome Therapeutics has released topline Phase III data for the same drug in major depressive disorder (MDD) that showed the drug was not successful overall. However, the proof-of-concept study showed an efficacy signal among patients with excessive sleepiness during the day, so the company plans to run another late-stage trial in that population.

Key Takeaways
  • As many expected, the Phase III PARADIGM study of solriamfetol failed in major depressive disorder, but showed signs of efficacy in patients with excessive daytime sleepiness.

Without announcing numerical data, Axsome unveiled results from the Phase III PARADIGM trial of solriamfetol in 51 patients with severe...

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