NEWS Mental Health News FDA Approves Auvelity, Faster-Acting Antidepressant By Zach Kortge Updated on October 11, 2022 Fact checked Verywell Mind content is rigorously reviewed by a team of qualified and experienced fact checkers. Fact checkers review articles for factual accuracy, relevance, and timeliness. We rely on the most current and reputable sources, which are cited in the text and listed at the bottom of each article. Content is fact checked after it has been edited and before publication. Learn more. by Karen Cilli Fact checked by Karen Cilli Karen Cilli is a fact-checker for Verywell Mind. She has an extensive background in research, with 33 years of experience as a reference librarian and educator. Learn about our editorial process Share Tweet Email Print d3sign/Moment/Getty Key Takeaways The FDA has approved Auvelity, a new antidepressant that may treat symptoms faster than other medications.The drug may be especially effective for individuals with treatment-resistant depression.Auvelity joins ketamine as a potential new wave of faster-acting antidepressants. Treatment for depression commonly includes the use of antidepressants, a treatment option that typically takes weeks to begin working. However, a newly approved medication may put an end to this waiting period. In August 2022 the FDA approved a drug called Auvelity which may offer faster relief for depression symptoms than other commonly used drugs. The medication is from the company Axsome, and is a combination drug that can be taken orally at home. Mechanism of the drug is based on earlier research looking into the effects of ketamine, an anesthetic, as a depression treatment. Dan Iosifescu, MD, professor of psychiatry at Langone Health, said the drug offers a new treatment for people who may not have had success with other medications. “(Auvelity is) a very interesting new drug that works differently than most of the other drugs on the market,” he said. Iosifescu was part of a group that designed and carried out clinical trials for the new depression drug. Study Shows Rapid Brain Response to Ketamine for Depression Here’s What Makes It Different In the August 19, 2022 Axsome press release, the FDA said the rapid-acting drug could offer treatment for clinical depression in as little as one week. This short treatment window is a stark difference to the four to six weeks it takes other depression medications to offer relief. Iosifescu said it can be frustrating for patients who have to wait additional time for a medication to work. Oftentimes, patients have already put off treatment for several months already before finding out about how much longer they must wait, he said. “The fact that something would work faster, is actually extraordinarily important because most of our antidepressants don’t,” he said. The difference in Auvelity’s time comes from how it works in the brain. Auvelity works on changing the levels of the neurotransmitter glutamate by acting on NMDA receptors. Antidepressants currently on the market modulate neurotransmitters like serotonin and noradrenaline. Auvelity would be the first medication of its kind, Iosifescu said. The category of drugs would be known as glutamate modulators, a group that includes ketamine. Research on ketamine as a treatment for clinical depression laid a basis for the current medication. Iosifescu said ketamine showed a fast, powerful antidepressant effect in research over the past decade, including research done by his own group. “(Ketamine treatment) was a very important change because it was the first time after several decades that we had something that works differently than all these other antidepressants,” he said. Dan Iosifescu, MD The fact that something would work faster, is actually extraordinarily important because most of our antidepressants don’t. — Dan Iosifescu, MD Auvelity works by combining two other drugs into one medication. Dextromethorphan is an older drug that has some modulating effects. The other drug in the combination, buproprion, is an antidepressant in its own right. However, the purpose of bupropion in this medication is to slow the metabolism of dextromethorphan. The new combination of drugs is a promising future for depression treatment, including a new treatment for patients whose condition has been resistant to other forms of medication. Although, Iosifescu said additional research is needed to look at that specifically. A New Drug in Practice The FDA approval of Auvelity marks the initial steps of the drug coming to market. FDA approval means the beginning phases of testing are over, and the drug can now be prescribed by physicians and used by patients. However, before that happens, several months of negotiations may take place between insurance companies and Axsome, the company that created Auvelity. Negotiations include the price of the new drug and stipulations for prescribing the medication. When a drug is new, it typically costs significantly more than older medications. Because of this increased cost, insurance companies often require patients to try older, cheaper medications first before trying a new one. “Technically, (Auvelity) would be quite as good and rapid acting in someone who hasn’t tried other antidepressants, but it’s also sort of a cost issue,” Iosifescu said. For patients who are prescribed Auvelity, they will take the extended-release tablet once a day for three days, then twice a day after that. Side effects during the clinical trials included dizziness, sleepiness, and headache. However, the new drug avoids other side effects common in some antidepressants. “It does not have any sort of weight gain,” Iosifescu said. “That’s sometimes a problem with some of the (older) antidepressants.” What This Means For You Although the medication is still in its initial release, he said it shows promise for helping anyone with major depressive disorder. And due to the medication's different mechanism of action, it has the possibility to help people who have had little success in treatment.“That’s to some extent, something that needs to be done from now on, to really test how good is this drug in specific populations,” Iosifescu said. “But in general, it’s a very interesting new drug that works differently than most of the other things on the market.” 3 Sources Verywell Mind uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy. Iosifescu DV, Jones A, O’Gorman C, et al. Efficacy and safety of axs-05 (Dextromethorphan-bupropion) in patients with major depressive disorder: A phase 3 randomized clinical trial(Gemini). J Clin Psychiatry. 2022;83(4). doi:10.4088/JCP.21m14345 Axsome. Axsome Therapeutics announces FDA approval of Auvelity, the first and only oral NMDA receptor antagonist for the treatment of major depressive disorder in adults. Schwartz J, Murrough JW, Iosifescu DV. Ketamine for treatment-resistant depression: Recent developments and clinical applications. Evid Based Mental Health. 2016;19(2):35-38. doi:10.1136/eb-2016-102355 See Our Editorial Process Meet Our Review Board Share Feedback Was this page helpful? Thanks for your feedback! What is your feedback? Other Helpful Report an Error Submit Speak to a Therapist Online Advertiser Disclosure × The offers that appear in this table are from partnerships from which Verywell Mind receives compensation.