Close

Key TakeawaysThe 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.

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 ofantidepressants, 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 theFDA approveda 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 ofketamine, 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.

Ketamine for Treatment-Resistant 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 forclinical depressionin 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.

“(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, MDThe fact that something would work faster, is actually extraordinarily important because most of our antidepressants don’t.

Dan Iosifescu, MD

The fact that something would work faster, is actually extraordinarily important because most of our antidepressants don’t.

The new combination of drugs is a promising future fordepression treatment, including a new treatment for patients whose condition has beenresistantto other forms of medication. Although, Iosifescu said additional research is needed to look at that specifically.

A New Drug in Practice

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 ofweight gain,” Iosifescu said. “That’s sometimes a problem with some of the (older) antidepressants.”

What This Means For YouAlthough 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.”

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.”

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 SourcesVerywell Mind uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto 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.21m14345Axsome.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

3 Sources

Verywell Mind uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto 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.21m14345Axsome.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

Verywell Mind uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto 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.21m14345Axsome.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

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

Meet Our Review Board

Share Feedback

Was this page helpful?Thanks for your feedback!What is your feedback?HelpfulReport an ErrorOtherSubmit

Was this page helpful?

Thanks for your feedback!

What is your feedback?HelpfulReport an ErrorOtherSubmit

What is your feedback?