FDA Approves First Fast-Acting Drug for Depression That Works Within 1 Week
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The FDA just approved the first-ever “fast-acting” drug to treat clinical depression.
The drug, Auvelity, from Axsome Therapeutics claims to start working within one week.
Clinical trials have found the drug to be safe and quickly effective in helping patients experiencing depression.
A new medication called Auvelity was just FDA-approved to treat major depressive disorder (MDD), also known as clinical depression, in as little as one week. The new “fast-acting” oral drug for clinical depression, from Axsome Therapeutics, could change the way we treat mental health.
The medication is the first of its kind and was granted Breakthrough Therapy Designation by the FDA. Auvelity is an N-methyl D-aspartate (NMDA) receptor antagonist, marking the first new type of medication to be approved for clinical depression in 60 years.
We chatted with experts to break down what makes this drug different than the rest of the SSRIs on the market—and why it’s such a game-changer.
What is Auvelity?
Auvelity is the first and only fast-acting oral treatment approved for statistically significant improvement in depressive symptoms in just one week compared to a placebo. The new medication is comprised of the two drugs dextromethorphan and bupropion, and should be available this year, but the price has yet to be announced.
In short, most antidepressant drugs work on the same neurotransmitters like dopamine and serotonin, but Auvelity focuses on glutamate receptors instead, Dan V. Iosifescu, M.D., professor of psychiatry at NYU Langone Health, a co-author on both the studies for Auvelity, and on the advisory board for this new drug tells Prevention.
He explains that for nearly 50 years there was nothing different in the science when it came to combating depression with medication. Then, there was a breakthrough with a medication called ketamine, which was able to work on a different mechanism within the brain to act as an antidepressant. The issue was that ketamine is somewhat addictive, and an FDA-approved version of it was only available in doctor’s offices with many restrictions.
Researchers set out to find a pill people could take at home that was safer but acted on the same receptor, says Dr. Iosifescu. That’s when they started looking at dextromethorphan, an older drug that works similarly but was metabolized in the body very quickly. He explains that if researchers could pair the drug with something that stayed it in the body longer, they could harness the brain benefits and use it to improve depressive symptoms. That’s when doctors paired it with bupropion, an existing antidepressant, which was able to allow dextromethorphan to metabolize slower in the body.
This new drug comes just after research indicated depression may not be a chemical imbalance at all—or as closely linked to serotonin as we once thought. “We see depression to be much more complicated than a chemical imbalance, but involving neuroplastic changes—the ability for the brain to rewire itself and change pathways,” explains Tracey Marks, M.D., a general and forensic psychiatrist and owner of Marks Psychiatry.
Dr. Marks suggests that current medications work as a “band-aid” by replacing serotonin levels instead of working on the problem itself. This new medication uses newer information to work similarly to ketamine but in a fast, well-tolerated manner, she says.
What does the research say?
Research published in the Journal of Clinical Psychiatry found in a double-blind phase three clinical trial, 163 patients taking Auvelity said their feelings of depression significantly improved within a week compared to those taking a placebo. Another double-blind study found patients who took the drug felt a reduction in depressive symptoms compared to those taking doses of sustained-released bupropion (an existing antidepressant) alone.
Who should try Auvelity?
For many people who experience clinical depression, commonly used antidepressants don’t work. These “treatment-resistant” patients need an alternative option, and that’s where this new drug comes in, Dr. Iosifescu explains to Prevention. He says that this new treatment option may be key in helping those patients who don’t respond to existing depression medications.
“Nearly two-thirds of patients treated with currently available antidepressants do not adequately respond, and those that do may not achieve clinically meaningful responses for up to six to eight weeks,” Maurizio Fava, M.D., psychiatrist-in-chief of the department of psychiatry at the Massachusetts General Hospital, said in a press release. “Given the debilitating nature of depression, the efficacy of Auvelity observed at one week and sustained thereafter may have a significant impact on the current paradigm for this condition.”
Additionally, many current drugs on the market take at least six weeks to see results, which can be far too long for someone looking to function properly. This new medication has the speed of ketamine, without the barriers and restrictions that come along with it, Dr. Marks says. “It opens the door for more people to get treatment without hesitancy,” she adds. “To have an option that’s supposed to work within a week is a huge intervention that will be very transformative.”
Are there risks associated with taking Auvelity?
Dr. Iosifescu says that Auvelity doesn’t have the same safety or addictive restrictions as ketamine, making it a much safer alternative. In general, it has similar side effects and warnings to existing antidepressant medications.
The medication information notes that Auvelity and other antidepressants may increase suicidal thoughts and actions in young adults, adolescents, and children. It’s essential to keep close attention to new or sudden changes in mood, behavior, thoughts, feelings, or suicidal thoughts when taking new medications of this nature.
Additionally, Auvelity is not for those with seizure disorders, eating disorders, or those taking certain medications like monoamine oxidase inhibitors, benzodiazepines, barbiturates, or anti-seizure medicines. Check with your healthcare provider about additional risks or side effects of the drug before taking it.
Symptoms of depression
According to the National Alliance of Mental Illness (NAMI), about 21 million U.S. adults had at least one major depressive episode in 2020. The mental health disorder impacts people of all ages, races, ethnicities, or socioeconomic backgrounds. If a person experiences depressive symptoms for more than two weeks, they can be diagnosed with depression. Common symptoms of depression include:
Changes in appetite
Changes in sleep
Lack of concentration
Loss of energy
Lack of interest in activities
Hopelessness or guilty thoughts
Less activity
Physical aches and pains
Suicidal thoughts
Depression treatments
Dr. Marks says that if your depressive symptoms are getting in the way of your day-to-day life, it’s time to speak to a medical professional about treatment options.
In addition to this new drug, people experiencing depression have many options for finding the best treatment that works for them. Additional antidepressants, mood stabilizers, and antipsychotic medications are available and can be prescribed by your healthcare provider. Psychotherapy (most often cognitive-behavioral therapy) with a therapist can also be done on its own or in tandem with medications, but this option requires time and commitment, Dr. Marks notes.
If you or someone you know is at risk, call the National Suicide Prevention Lifeline at 1-800-273-TALK (8255) or text HOME to 741741 to message a trained crisis counselor from the Crisis Text Line for free.
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