FDA Approves a novel drug, Auvelity for management of Clinical Depression

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FDA Approves a novel drug, Auvelity for management of Clinical Depression

Recently, the FDA certified a new drug called Auvelity to address major depressive disorder (MDD), usually referred to as chronic depression, in just as 7 days. The “fast-acting” oral depression medication from Axsome Therapeutics has the potential to revolutionize the way we approach mental health care.

The FDA designated the drug as a breakthrough therapy since it is the first of its kind. N-methyl D-aspartate (NMDA) receptor antagonist Auvelity is the first novel drug for clinical depression to be licensed in 60 years.

In order to understand how this medication differs from the other SSRIs available on the market—and why it’s such a game-changer—let’s highlight the overall role of this medication.

What is Auvelity?

Within 7 days, contrasted to a placebo, Auvelity is still the only fast-acting oral medication certified for a clinically noticeable difference in depression symptoms. The new treatment, which combines the two medications dextromethorphan and bupropion, should be made accessible this year, though the cost has not yet been disclosed.

In brief, whereas Auvelity concentrates on glutamate synapses, most antidepressant medications target the very same neurotransmitters like dopamine and serotonin.

When it comes to using drugs to alleviate depression, research had not changed in almost fifty years. Then, a medicine known as ketamine made a breakthrough by acting as an antidepressant by acting on a different brain mechanism. The problem was that the FDA-certified form of ketamine was only accessible with severe limitations in medical clinics and that it has certain psychoactive effects.

This new medication was developed soon after studies revealed that depression may not actually be caused by a chemical imbalance or be as closely related to serotonin as previously believed. According to a psychiatrist, a general and forensic psychiatrist and owner of Marks Psychiatry, “We consider depression as much more involved than a chemical imbalance, but including neuroplastic changes—the potential for the brain to remodel itself and modify pathways.”

Recent research

According to study findings in the Journal of Clinical Psychiatry, 163 people receiving Auvelity reported considerably fewer depressive symptoms in just 7 days compared to those taking a placebo. This was in a double-blind phase 3 controlled study. Another double-blind trial discovered that patients receiving the medication experienced fewer depressive symptoms than those taking a dosage of sustained-released bupropion (another antidepressant) by itself.


“Nearly two-thirds of patients receiving antidepressant treatment do not react sufficiently, and those who do may not have medically significant improvements for up to six to eight weeks,” says the study.

The effectiveness of Auvelity seen at 7 days and maintained subsequently may have a considerable impact on the present paradigm of treating this condition, given the crippling nature of depression. Furthermore, many of the medications currently readily available on the industry require at least six weeks to start working, which can be an extremely long time for someone trying to get by. This novel drug has the speed of ketamine without the obstacles and limitations that accompany it.

Risk and other considerations

Auvelity is a considerably safer option to ketamine because it doesn’t have the same compulsive constraints. It generally has adverse effects and cautions similar to those of antidepressant drugs now on the market.

According to the pharmaceutical guide, young people, teenagers, and kids may have an upsurge in suicidal thoughts when taking Auvelity and other antidepressants. When using new medications of this kind, it’s important to pay particular attention to any sudden or new shifts in mood, attitude, ideas, emotions, or suicidal thinking.

Auvelity is also not recommended for those with eating disorders, seizure disorders, or who are using specific medicines, such as benzodiazepines, monoamine oxidase inhibitors, anti-seizure meds, or barbiturates. Before using the medication, speak with your doctor about any potential adverse reactions or increased dangers.

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