USA- The US Food and Drug Administration (FDA) has approved Auvelity by Axsome Therapeutics (US) for the treatment of Major Depressive Disorder (MDD) in adults.
Results from Axsome Therapeutics’ Phase III clinical research GEMINI (NCT04019704), were used to support the approval of the drug.
The research was a six-week, double-blind, placebo-controlled experiment to evaluate the safety and efficacy of Auvelity in patients with moderate-to-severe MDD.
Auvelity is composed of Bupropion, a medication used to treat depression, and dextromethorphan, a substance most commonly used to treat coughs.
While bupropion increases the quantity of dextromethorphan present in the body, dextromethorphan operates on the N-methyl D-asparate (NMDA) neurotransmitter, which regulates mood.
“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.
Auvelity’s quick beginning of action will represent a significant advance in the MDD market, where there is substantial unmet demand for pharmacotherapies that can demonstrate immediate antidepressant benefits.
Seeking approval in cases of depression has been challenging. In 2019, Axsome released encouraging findings from a Phase 3 trial and then submitted an application based on those data and the outcomes of a mid-stage study.
Axsome said that the FDA had discovered “deficiencies” in its petition in August of last year.
The agency’s review deadline passed without a resolution, putting the treatment’s future up in the air.
Auvelity’s quick beginning of action will represent a significant advance in the MDD market, where there is substantial unmet demand for pharmacotherapies that can demonstrate immediate antidepressant benefits.
The antidepressant effects of currently available medications, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), appear only after several weeks of therapy.
In many cases, the dosage must be optimized or medications must be combined to provide the greatest therapeutic benefit.
Although Axsome hasn’t yet disclosed pricing, GlobalData believes it will be higher than the affordable, generic anti-depressants, which are already well-known on the MDD market.
Auvelity’s use may be limited to second and later lines of therapy once cheaper alternatives have been tried, which would limit potential revenue given its estimated annual cost of more than US$1,000.
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