With FDA approval, Axsome touts Auvelity as a potential game-changing depression treatment

The lack of adequate treatment options for major depressive disorder has been well documented. Then came the pandemic, adding more patients diagnosed with MDD and heightening the unmet need.

With that, the timing is good for the approval of a potentially game-changing drug to treat MDD. On Friday, the FDA signed off on Axsome Therapeutics’ Auvelity, the first rapid-acting oral treatment for MDD.

The major difference between Auvelity and the current roster of antidepressants on the market is its ability to work quickly. While the typical response time for current antidepressants is six to eight weeks or longer, New York University depression expert Dan Iosifescu, M.D., said during a conference call, Auvelity’s benefits can be seen within a week.

“With symptom improvement happening at week one and then remission happening by week two, the combination of those two is incredibly differentiating in the marketplace right now,” Lori Englebert, Axsome’s EVP, commercial and business development, said. “If you look at the high unmet need that remains in the market—two-thirds of patients don’t achieve remission and physicians are now moving toward remission as the goal of treatment—we’re pretty excited about the product.”

News of the approval sent Axsome’s shares soaring—from $42.46 at close on Thursday to $58.00 by mid-morning on Friday for a 36.6% increase.

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As an N-methyl D-asparate (NMDA) receptor antagonist, Auvelity is the first oral MDD drug to enter the market with a new mechanism of action in more than 60 years, the press release noted.

In 2020, Johnson & Johnson’s nasal spray Spravato was sanctioned as the first NMDA receptor antagonist for MDD. But its label is narrower than that of Auvelity, which can be used as a front-line treatment.  

Axsome said it expects to launch Auvelity in the fourth quarter. Its price will be determined in the coming weeks, Englebert said during the call. To market the drug outside of the U.S., the company said it will seek a commercial partner.

In the clinic, Auvelity was tested on 1,100 depression patients. In the Gemini study, Auvelity showed statistically significant superiority to placebo in improvement of depressive symptoms as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6, the study’s primary endpoint. The difference between Auvelity and placebo in change from baseline in the MADRS total score was statistically significant at Week 1 and at Week 2.  

In the Ascend study, Auvelity was statistically significantly superior to bupropion sustained-release tablets on the primary outcome measure, which was calculated by assessing the change from baseline in MADRS total scores from Week 1 to Week 6 and then taking the average of those scores. 

“It’s rapid acting. It does have a very substantial magnitude of effect. You get remission quickly and at high rates and it’s also very well tolerated,” Axsome CEO Herriot Tabuteau said during the call. “It’s the confluence of all those attributes which make it compelling.”

It’s been a busy time for Axsome. To secure the delayed approval, the company had to answer for deficiencies that the FDA identified in its application last year. On Friday, Tabuteau said those related to chemistry, manufacturing and controls (CMC) and were resolved early in the year.

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Three months ago, Axsome acquired sleep apnea and narcolepsy drug Sunosi from Jazz Pharmaceuticals for an upfront payment of $53 million. The drug generated sales of $58 million last year for Jazz.

But also in May, the FDA rejected Axsome’s migraine treatment AXS-07. The company has two candidates in phase 3—AXS-12 for narcolepsy and ASX-14 for fibromyalgia—both of which have “potential NDA filings in 2023,” Tabuteau added during the call.