FDA Approves Auvelity, a New Medication for Clinical Depression

The fast-acting pill may start to work within 1 week.

Fact-Checked
Auvelity 45 mg  105 mg prescription bottle
The new prescription drug should be available by the end of the year.
Axsome Therapeutics; Canva

The U.S. Food and Drug Administration on August 19 approved dextromethorphan-bupropion, or Auvelity, a drug used to treat major depressive disorder, also known as clinical depression, in adults.

It is the first drug to treat major depressive disorder that works within a week of taking it and is the first new pill to treat depression using a new mechanism of action in more than 60 years, according to the manufacturer,?Axsome Therapeutics.

What’s Different About This Depression Drug

There has long been a need for better and more effective drugs to treat depression, as nearly two-thirds of all people diagnosed with depression do not find relief from them, according to Axsome Therapeutics.

In a double-blind phase 3 clinical trial, 163 patients taking Auvelity said their feelings of depression were significantly improved within a week of beginning the drug, as opposed to 164 patients who took a placebo, according to?research published in the Journal of Clinical Psychiatry in May 2022. The drug is as an N-methyl D-aspartate (NMDA) receptor antagonist.

In another randomized double-blind multicenter?study of 97 patients with major depression, published in the American Journal of Psychiatry in May 2022, patients who took the combination of dextromethorphan-bupropion, as compared with those who took doses of sustained-release buproprion, reported that their depression symptoms were “significantly reduced” on the Auvelity medication. Current depression medications typically need to be taken consistently for about six weeks before patients report feeling better, the company said.

New Drug May Deliver Fast-Acting Treatment

“The main advantage demonstrated in the clinical trials is faster onset of action,” says Joseph E. Comaty, PhD, a retired clinical psychologist and medical psychologist licensed to prescribe medication in Louisiana. Dr. Comaty's primary area of research was clinical psychopharmacology, focusing on the clinical treatment for the major psychiatric disorders of schizophrenia, major depression, and bipolar disorder. “Auvelity demonstrated improvement in depression rating scale scores compared to placebo at one week of treatment. Usually, it takes several weeks to show a response with current antidepressant treatments. The only other depression treatment shown to act as quickly as Auvelity is ketamine.”

As Depression Rates Climb, New Treatments Are Welcome

Clinical depression rates increased 25 percent around the world as a result of the COVID-19 pandemic, according to the?World Health Organization (WHO). Axsome Therapeutics stated that approximately 80 million American adults have experienced depression since the pandemic. “Nearly two-thirds of diagnosed and treated patients do not experience adequate treatment response with available first-line treatment, highlighting the need for new therapies,” stated an Axsome press release.

Signs and Symptoms of Clinical Depression

A person is considered clinically depressed if they consistently experience?at least five depressive symptoms, including some of the following, for at least two weeks:

  • Feels low or depressed
  • Loss of interest or pleasure in activities they once enjoyed
  • Feels guilty or worthless
  • Lacks energy
  • Cannot concentrate
  • Has appetite changes
  • Sleeps poorly
  • Moves and speaks more slowly than usual
  • Is suicidal

Depression is considered “a common but serious mood disorder that causes severe symptoms that affect how you feel, think, and handle daily activities, such as sleeping, eating, or working,” according to the National Institute of Mental Health (NIMH).

People with untreated depression are at higher risk of worsening symptoms if they have other health issues, such as diabetes, cancer, or heart disease. Even without such diagnoses, untreated depression can make it hard to function, so a person may have trouble keeping or maintaining relationships or working productively at a job or school. Someone with untreated depression may turn to recreational drugs, alcohol, or thoughts of suicide as a coping mechanism.

Call or text 988?for urgent help with a mental health crisis; earlier this year,?988 became the new direct line to the Suicide and Crisis Lifeline.

It's important to reach out to get help for depression. That can include talk therapy, and sometimes medication. Some people may begin taking medication, feel more hopeful on it, and then stop taking it because they don’t feel depressed any longer. But this can cause depression to return. It’s crucial to work with a healthcare provider when taking medication; you should never simply stop taking it if you are dealing with depression.

Talk to your doctor about any other medications you are on to see if they may interact with Auvelity, particularly drugs used to treat depression known as MAOI antidepressants, SSRIs, or tricyclic antidepressants. Also ask your provider if taking Auvelity along with mental health consultation or talk therapy is advisable for you.

Auvelity is an extended-release tablet taken by mouth once a day for the first three days of use, then increased to twice a day at least eight hours apart. The drug is made up of two ingredients, dextromethorphan (a cough suppressant) and bupropion (Wellbutrin), which work together to regulate chemicals in the brain linked to depression. It is composed of 45 milligrams (mg) of dextromethorphan hydrobromide and 105 mg of bupropion hydrocholoride.

“There are patients who should not use Auvelity or for whom caution should be exercised when considered its use,” says Comaty. “The manufacturer states that Auvelity should not be used in individuals with seizure disorders, eating disorders, those individuals who may be prone to seizures due to recent discontinuation of heavy drinking, or discontinuation of the use of benzodiazepines, barbiturates, or antiseizure medications, those individuals who are on a class of antidepressants known as MAOI inhibitors, or individuals who may be at increased risk of suicide.”

The Auvelity?prescribing label carries a?black box warning for a possible link to suicidal thoughts and behaviors: “Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors.” The drug is not approved for use in children.

Common side effects associated with Auvelity include dizziness, headache, diarrhea, feeling sleepy, dry mouth, sexual function problems, and excessive sweating.

Drug Should Be Available This Year; Price Has Not Been Set?

The medication is expected to be available to patients by prescription from their healthcare providers in the fourth quarter of 2022. The company said it will set the drug’s prices in the coming weeks.

“As with any new drug, once it is available for use in everyday clinical practice, we may get a better understanding of its effectiveness, who might be best suited to receive the drug, and its risks,” says Comaty.

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