The US Food and Drug Administration has approved Geparon ER, sold under the brand name Exxua, a first-of-its-kind medication for treating major depressive disorder (MDD), Fabre-Kramer Pharmaceuticals announced last week.
The drug is unique in that it selectively targets the serotonin 1A receptor in the brain, according to Science Direct. Serotonin plays a key role in mood function. By stimulating the 1A receptor, not only does it regulate serotonin, but it also causes the release of dopamine, a chemical that is key to the sending of signals in the brain.
“Other treatments for depression either do not target the serotonin 1A receptor, or if they do, they also interact with numerous other receptors,” says Stephen Stahl, MD, professor of psychiatry at the University of California, San Diego, and founder of the Neuroscience Education Institute. “Exxua is the only drug currently approved for depression that selectively targets the serotonin 1A receptor.”
Fabre-Kramer also points out that its approved labeling contains no “warnings or adverse reactions” about sexual dysfunction or weight gain.
Sexual problems and weight gain are common problems with other antidepressants, especially generic first-line serotonin selective reuptake inhibitors (SSRIs), according to Dr. Stahl, who was not involved in any research related to the drug.
“The lack of such problems is one of the distinguishing features of Exxua and one of the great potential advantages of Exxua,” he says.
The drug was approved by the FDA after years of research involving more than 5,000 patients. Clinical trials have shown that Exxua has an overall acceptable safety profile, with the most common side effects being dizziness and nausea, which were generally mild and didn’t last long. The drug is taken once daily and has an extended and controlled release over 24 hours.
Dr. Sanjay Mathew, medical director of the Anxiety and Depression Association of America and a professor of psychiatry and behavioral sciences at Baylor College of Medicine in Houston, said the drug’s long-term effects on sexual function and weight gain have not been studied.