Axsome’s Fast-Acting Depression Drug Gains FDA Approval after a Year-Long Review

The US Food and Drug Administration has finally given the long-awaited approval on Axsome Therapeutics’ depression drug. The approval has come after almost a year-long delay due to deficiencies in the company’s application that the FDA highlighted in August 2021. The drug, formerly called AXS-05, will be available for purchase in the last quarter of this year under the name Auvelity.

The lack of advanced, effective treatment options for depression (major depressive disorder) is well-known. This results in poor quality of life and leaves many struggling on a daily basis. Axsome Therapeutics’ Auvelity addresses the unmet need of hundreds of thousands of people suffering from MDD with its fast-acting mechanism, which is the primary factor that makes it stand out from the current roster of antidepressants on the market. 

The response time for antidepressants that are currently available is six to eight weeks at minimum. But, according to what experts tell, Auvelity can show results within a week. Along with a quick improvement in symptoms, the patients can achieve remission by week two. As Lori Englebert, EVP Commercial and Business Development at Axsome, said, “The combination of these two is incredibly differentiating in the marketplace right now.” With the news of FDA approval becoming public, Axsome’s shares increased by over 36% within just a few hours.

Auvelity is the First of Its Kind

Auvelity is an NDMA (N-methyl D – aspartate) receptor antagonist drug, the first of its kind in the antidepressant drugs sector. Spravato by Johnson & Johnson, which was previously (in 2020) endorsed as the first NDMA receptor antagonist drug for major depressive disorder, has a narrower mechanism of action than Axsome’s drug. Moreover, Spravato comes in the form of a nasal spray, whereas Auvelity is an oral medicine.

 It’s the only NDMA receptor antagonist drug for MDD to be available as oral medicine. The broader label and pill form of Auvelity makes it a more viable option to be used as a first-line medication for MDD.

Auvelity Advantage over Other Drugs in Clinical Studies

In clinical studies, Auvelity was found significantly superior to both placebo and bupropion sustained-release tablets in improving symptoms of MDD.

Auvelity Is the Ray of Light for Millions of Americans

With its rapid-acting mechanism, the substantial magnitude of effects, ability to put people into remission quickly, and high tolerance, Auvelity offers hope to more than 17 million American adults who suffer from major depressive disorder[1]. The hope for relief and living a better quality of life.

What’s Next for Axsome?

With finally getting the FDA’s approval after about a year-long extended review, Axsome is now preparing for the commercial release of the world’s first fast-acting antidepressant drug. But it’s not going to be an easy ride building the market for a brand new therapy. The company will have to invest a significant amount of time and money in building the marketing campaign and ensuring the availability of the drug.

Axsome Therapeutics hasn’t decided on the price for the drug yet but intends to start discussions on it with insurers in the coming few weeks, as it plans to begin rolling out the medicine for public use by the last quarter of this year.