Please ensure Javascript is enabled for purposes of website accessibility

FDA Begins Priority Review of Axsome Therapeutics' Potential New Depression Drug

By Cory Renauer - Updated Apr 26, 2021 at 1:18PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

A new treatment for millions of Americans with major depressive disorder could become available this summer.

Millions of Americans who experience debilitating bouts of depression could have a new treatment option this summer. On Monday, the FDA began reviewing a New Drug Application from Axsome Therapeutics (AXSM 6.11%) for its lead candidate, AXS-05.

Instead of the standard review that takes 10 months, the FDA gave AXS-05 a Priority Review that shaves four months off the process. The agency expects to issue a decision on or before Aug. 22.

Smiling doctor

Image source: Getty Images.

Both active ingredients in AXS-05, bupropion and dextromethorphan, are well-understood drugs that complement each other. In the pivotal Gemini study, patients treated with AXS-05 were more than twice as likely to achieve remission than the placebo group. Strong data, decades of experience with the active ingredients, and a lack of safety issues with AXS-05 so far make its approval seem like a foregone conclusion.

An estimated 7.8% of American adults experience major depressive disorder each year, and many of them could use a novel new drug. Popular serotonin reuptake inhibitors (SRIs) like Celexa and Zoloft get the job done for some, but roughly a third don't respond well to their first two attempts at treatment. 

Bupropion isn't free from side effects, but it's a walk in the park compared to the average SRI, and it's already prescribed around 24 million times a year for depression and smoking cessation. Pharmacies in the U.S. fill out about 88 million prescriptions for the three most popular SRIs each year. This means approval for AXS-05 this summer could be its first step on the way to becoming one of the country's most prescribed drugs. 

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Axsome Therapeutics, Inc. Stock Quote
Axsome Therapeutics, Inc.
AXSM
$40.64 (6.11%) $2.34

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
316%
 
S&P 500 Returns
112%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 07/03/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.