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Fabre-Kramer Pharmaceuticals gains FDA approval for EXXUA for major depressive disorder

The U.S. Food and Drug Administration (FDA) has approved Fabre-Kramer Pharmaceuticals’ Exxua (gepirone hydrochloride extended-release tablets) for the treatment of major depressive disorder (MDD) in adults.

Exxua represents a new class of antidepressant; the first and only approved antidepressant with a novel mechanism of action that selectively targets the serotonin 1A receptor, a key regulator of mood and emotion. Exxua has been shown to effectively relieve depressive symptoms, and its approved labeling does not contain Warnings or Adverse Reactions regarding causing sexual dysfunction or weight gain vs. placebo. Exxua is expected to be available in pharmacies in early 2024.

Studied in over 5,000 patients, EXXUA’s unique mechanism of targeted single serotonin (5HT) 1a receptor agonism relieves depressive symptoms with an acceptable side effect profile. Sexual side effects experienced with EXXUA treatment in clinical trials were comparable to placebo and did not meet the incidence criteria for inclusion in the Adverse Reaction section of EXXUA’s label.

EXXUA also showed an overall acceptable safety profile, with no significant adverse effect on weight, blood pressure, heart rate or liver function. The most frequent adverse events seen in clinical trials were dizziness and nausea, which generally were mild, of short duration, related to dose escalations and did not require discontinuation of treatment.

Anita H. Clayton, MD, Chair, Department of Psychiatry & Neurobehavioral Sciences, University of Virginia School of Medicine, a renowned clinician and researcher of sexual dysfunction issues in MDD treatment said: “I am thrilled for our patients that EXXUA (gepirone ER) is now FDA approved for the treatment of major depressive disorder (MDD). EXXUA is the first 5-HT1a agonist with superior efficacy vs. placebo as MDD monotherapy, yet did not differ from placebo in rates of sexual dysfunction in clinical trials. This provides an important new treatment option for patients.”

“EXXUA represents an important milestone in the treatment of MDD, a serious and debilitating condition that affects millions of people worldwide,” said Stephen Kramer, M.D., CEO of Fabre-Kramer. “There is value in providing prescribers and patients with a wide range of effective options for use in clinical practice. We are proud to bring this innovative therapy to patients who need a new option to manage their depression and improve their quality of life.”

Michael Pollack, Chief Executive Officer of the Depression and Bipolar Support Alliance (DBSA), a leading national patient advocacy organization said: “The mental health crisis in the United States is one of the most pressing health issues facing our country today. Over 20 million American adults experienced major depressive disorder each year prior to the COVID-19 pandemic. These numbers increased dramatically during the pandemic with approximately 30% of adults in the US or more than 80 million Americans experiencing elevated symptoms of depression. The need for new treatment options, particularly those with new mechanisms of action, could not be clearer and more urgent for those living with, or impacted by, major depressive disorder.”

The mechanism of the antidepressant effect of EXXUA is not fully understood but is believed to be related to its modulation of serotonin activity in the CNS through selective agonist activity at 5HT1a receptors. EXXUA and its active metabolite exhibit exclusive and strong binding affinity for 5HT1a receptors.

Dr. Stephen Stahl, Professor of Psychiatry, University of California and founder of the Neuroscience Education Institute, a recognized expert neuropsychopharmacologist said: “EXXUA is the first truly selective agonist of the serotonin 1a receptor that has been consistently linked to mediation of mood disorders and suicide risk. It’s an important addition to the armamentarium to treat depression.”


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