February 26, 2024

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Breakthrough in depression treatment: FDA Approved Oral Therapy Auvelity

Breakthrough in depression treatment: FDA Approved Oral Therapy Auvelity


Breakthrough in depression treatment: FDA Approved Oral Therapy Auvelity.

60 years of new breakthroughs in depression treatment! FDA Approves New Mechanism for Oral Therapy Auvelity.


A year after delaying approval, Axsome finally had good news.

On August 19,  FDA approved Axsome’s NMDA (N-methyl D-aspartate) receptor antagonist Auvelity (a sustained-release combination of 45mg dextromethorphan and 105mg bupropion) for marketing. For the treatment of major depressive disorder in adults.


Axsome said that Auvelity is the first oral NMDA receptor antagonist approved for the treatment of depression and a milestone in the treatment of depression in 60 years.


Breakthrough in depression treatment: FDA Approved Oral Therapy Auvelity



Auvelity is a combination of two approved drugs: bupropion, the active ingredient in GSK’s antidepressant Wellbutrin, and dextromethorphan, one of the common ingredients in several cough medicines.

In this combination, dextromethorphan acts as an NMDA receptor antagonist and plays a role in regulating glutamate neurotransmission; while bupropion can increase the bioavailability of dextromethorphan, and can also act as norepinephrine and dopamine. Reuptake inhibitors work.


The efficacy and safety of Auvelity was validated in a comprehensive clinical development program involving more than 1,100 patients with depression.


Results from the Phase III study GEMINI were positive: Auvelity significantly improved Week 6 MADRS (Depression Rating Scale) scores over placebo.

Auvelity worked quickly, showing a statistically significant antidepressant effect in the first week, in stark contrast to the placebo group.

After 2 weeks of treatment, the proportion of patients in remission was more than twice as high as in the placebo group.


“This early benefit to Auvelity continued and increased with continued treatment, and was accompanied by a favorable safety and tolerability profile,” Axsome said in a press release.


In the ASCEND trial, Auvelity significantly improved 6-week mean MADRS scores (primary endpoint) over 105 mg twice-daily bupropion extended-release tablets.


In placebo-controlled clinical studies, the main side effects of Auvelity were dizziness, headaches and other central symptoms, with an incidence of ≥5%, more than twice that of placebo, but Axsome said it was within the expected range.


Major depression is not a rare disease. There are about 300 million patients worldwide, but about 2/3 of the patients do not respond well to current depression treatments, and even some patients cannot achieve clinically meaningful responses after up to 6-8 weeks of treatment. 

Ketamine was the first NMDA receptor modulator to be marketed, and inhaled formulations have limited its use.

The search for NMDA receptor antagonists with better pharmacokinetic properties has never stopped, but there has been no successful case before Auvelity.


Auvelity submitted a marketing application in August 2021, but the FDA announced a delay in its approval decision due to a flawed new drug application.


Fortunately, only good things happen. Shares of Axsome began to soar on the news of the approval for depression, rising 40% to $59.55 by the end of the session on Aug. 19.


It is reported that in addition to being approved for the treatment of depression, this innovative therapy has also been granted a breakthrough therapy designation by the FDA for the treatment of agitation symptoms in patients with Alzheimer’s disease. Phase III clinical trials are currently underway.


While awaiting approval, Axsome has assembled a sales team of 165 employees. The sales force will serve about 25,000 U.S. health care providers, including psychiatrists and other mental health consultants, according to the company. These industry players will cover about 70% of Auvelity’s addressable market.

Axsome did not announce pricing for the product, saying only that the company will make pricing decisions based on “ensuring widespread availability for patients” and “supporting the value of Auvelity’s treatment.”


Cantor Fitzgerald analyst Charles Duncan pointed out in a report that Auvelity is expected to reach peak annual sales of $2.2 billion and will eventually account for 5% of the major depression market. The product is expected to be priced around $7,500 per year.


Auvelity is the first successfully approved product of Axsome’s self-developed pipeline. It is reported that the patent protection of this drug will last until 2037-2040.







1.Axsome’s Wait Pays Off With Broad Auvelity Label For Major Depression

2.axsome therapeutics announces fda approval of auvelity™, the first and only oral nmda receptor antagonist for the treatment of major depressive disorder in adults

The first in 3.60 years! FDA Approves New Mechanism for Oral Therapy for Depression; WuXi AppTec

Breakthrough in depression treatment: FDA Approved Oral Therapy Auvelity

(source:internet, reference only)

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