Axsome Plans Excessive Sleepiness Study In Depression After Phase III Failure

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...

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Neurological

Sanofi Makes Alzheimer’s Bet With Vigil Buy

 
• By 

The French drugmaker is expanding its neurology activities with the $470m deal.

In Brief: US FDA Delay Sends Biohaven Shares Down

 

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

Multiple Launches Help Lilly’s Japan Growth

 
• By 

Lilly saw solid growth for its business in Japan last year on the back of several new launches and is building its obesity and Alzheimer's portfolios in the country.

Lundbeck Lifted By Leap In Migraine Therapy Sales

 
• By 

Vyepti revenues rise by nearly 70% in the first quarter.

More from Scrip

New Vaccine Framework Avoided Worst-Case Scenario, Analysts Say

 
• By 

The new US FDA vaccine guidelines introduced on 20 May might cause financial woes for Moderna, but overall vaccine makers should not be as impacted as feared.

Genentech, Orionis Stick Together In Second Molecular Glue Deal

 

Deal Snapshot: Orionis and Genentech signed a new partnership focused on molecular glues, on top of the one that they struck in 2023.

Finance Watch: Prime, Kyverna, Allogene And More Announce Job Cuts

 
• By 

Restructuring Edition: Prime Medicine ended its sole clinical-stage program to prioritize preclinical and partnered programs, cutting 25% of its workforce to extend its cash runway. Meanwhile, earnings season brought workforce reductions at Kyverna, Allogene, Leap and others.