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...
Without announcing numerical data, Axsome unveiled results from the Phase III PARADIGM trial of solriamfetol in 51 patients with severe excessive daytime sleepiness (EDS) and 295 patients without EDS. The...
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