FDA Approves Gepirone (Exxua) for Major Depressive Disorder
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The U.S. Food and Drug Administration (FDA) has approved gepirone ER, sold under the brand name Exxua, a first-in-class medication for the treatment of major depressive disorder (MDD), according to an announcement last week from drug manufacturer Fabre-Kramer Pharmaceuticals.
The medication is unique in that it selectively targets the serotonin 1A receptor in the brain, as detailed by Science Direct. Serotonin plays a key role in mood function. By stimulating the 1A receptor, it not only regulates serotonin, it also causes the release of dopamine, a chemical key to sending signals in the brain.
“Other treatments for depression either do not engage the serotonin 1A receptor, or if they do, also interact with numerous other receptors,” says Stephen Stahl, MD, a professor of psychiatry at the University of California in San Diego and founder of the Neuroscience Education Institute. “Exxua is the only medication currently approved for depression that selectively engages the serotonin 1A receptor.”
Fabre-Kramer also highlights that its approved labeling does not contain “warnings or adverse reactions” about sexual dysfunction or weight gain.
Sexual problems and weight gain are common problems with other antidepressants, especially first line generic serotonin selective reuptake inhibitors (SSRIs), according to Dr. Stahl, who was not involved in any research related to the medication.
“Lack of such problems is one of the distinguishing features of Exxua and one of its great potential advantages,” he says.
The drug gained FDA approval after years of research involving more than 5,000 patients. Clinical trials have shown the Exxua has an overall acceptable safety profile, with the most frequent side effects being dizziness and nausea, which generally were mild and didn’t last long. The medication is taken once a day, and has extended and controlled release over 24 hours.
Whether or not side effects related to sexual function and weight gain appear over time in real-life use, however, remains a question, according to Sanjay Mathew, MD, chief medical officer for the Anxiety and Depression Association of America and a professor of psychiatry and behavioral sciences at Baylor College of Medicine in Houston.
“We have to see how this plays out in practice,” he says.
Dr. Mathew adds that the medication’s antidepressant mechanism is not completely novel in his view. He cites the anti-anxiety medication buspirone, which similarly acts on the serotonin 1a receptor.
An Additional Therapeutic Option for a Major Health Problem
Even with those considerations in mind, Mathew says the drug, which is expected to be available in 2024, will offer another treatment option for the estimated 21 million American adults who live with major depressive disorder, also known as clinical depression, per the National Institute of Mental Health.
MMD is characterized by persistent feelings of sadness and loss of interest, according to Mayo Clinic, and those who experience it can have a range of emotional and physical problems that make it difficult to do day-to-day activities.
“It’s different from just depression in that it’s a constellation of symptoms that not only include sadness or low mood, but also a loss of the ability to experience pleasure or reward,” says Mathew. “There may be changes in appetite, concentration, and energy levels, as well as sleep difficulties and in some cases, suicidal thoughts or behaviors.”
He expects that Exxua may be prescribed in some cases where people with depression have not tolerated or responded to more established standard antidepressants.
“The drug is an important addition to the armamentarium to treat depression,” says Stahl, who advises people with major depression to consult with a medical professional to see if the medication may be right for them.
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