FDA Approves Auvelity, Faster-Acting Antidepressant


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.

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.”

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