New treatment for clinical depression approved by the FDA

The U.S. Food and Drug Administration on Aug. 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 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 Medication

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 it, according to Axsome Therapeutics.

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

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

New drug may provide fast-acting treatment

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

As depression rates soar, new treatments are welcome

According to the World Health Organization (WHO), rates of clinical depression have increased by 25% worldwide as a result of the COVID-19 pandemic. Axsome Therapeutics said about 80 million American adults have suffered from depression since the pandemic. “Almost two-thirds of patients diagnosed and treated do not experience an adequate response to treatment with available first-line therapy, underscoring the need for new therapies,” said a press release from Axsome.

Signs and Symptoms of Clinical Depression

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

  • Feels weak or depressed
  • Loss of interest or pleasure in activities they once enjoyed
  • Feels guilty or worthless
  • Lack of energy
  • can’t concentrate
  • Has appetite changes
  • Sleep badly
  • Moves and talks slower than usual
  • is suicidal

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

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

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

It is important to reach out for help for depression. This can include talk therapy and sometimes medication. Some people may start taking medication, feel more hopeful, and then stop taking it because they no longer feel depressed. But it can cause the depression to return. It is crucial to work with a health care provider when taking medication; you should never just stop taking it if you suffer from depression.

Talk to your doctor about any other medicines you take to see if they may interact with Auvelity, especially medicines used to treat depression called MAOIs, SSRIs, or tricyclic antidepressants. Also ask your provider if taking Auvelity with mental health counseling or talk therapy is recommended 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 made up of 45 milligrams (mg) of dextromethorphan hydrobromide and 105 mg of bupropion hydrochloride.

“There are patients who should not use Auvelity or for whom caution should be exercised when considering its use,” Comaty says. “The manufacturer states that Auvelity should not be used in people with seizure disorders, eating disorders, people at risk of having seizures due to recent cessation of excessive alcohol consumption or stopping the use of benzodiazepines, barbiturates, or anticonvulsant drugs, those people taking a class of antidepressants known as MAOI inhibitors, or people who may be at increased risk of suicide.

Auvelity’s prescription label bears a black box warning of a possible link to suicidal thoughts and behaviors: “Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants.” Closely monitor all patients treated with antidepressants for clinical worsening and the 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, problems with sexual function, and excessive sweating.

The drug should be available this year; The price has not been set

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

“As with any new drug, once it is available for use in daily clinical practice, we can better understand its effectiveness, who might be best placed to receive the drug, and its risks,” Comaty says.

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