Exxua FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 26, 2023.
FDA Approved: Yes (First approved September 22, 2023)
Brand name: Exxua
Generic name: gepirone
Dosage form: Extended-Release Tablets
Company: Fabre-Kramer Pharmaceuticals, Inc.
Treatment for: Major Depressive Disorder
Exxua (gepirone) is an azapirone antidepressant for the treatment of adults with major depressive disorder.
- Major depressive disorder (MDD) is a debilitating disorder characterized by low mood, inability to feel pleasure, feelings of worthlessness, low energy, and other emotional and physical symptoms, and impairment of important functioning. In severe cases, MDD can result in suicide.
- Exxua contains gepirone, an azapirone antidepressant thought to work by modulation of serotonergic activity in the central nervous system through selective agonist activity at serotonin (5HT) 1A receptors. This unique mechanism of action allows for the relief of depressive symptoms without significant side effects seen with other antidepressants, including sexual dysfunction and weight gain.
- Exxua is administered orally, once daily with food at approximately the same time each day.
- The Exxua product label carries a Boxed Warning for the increased risk of suicidal thinking and behavior in pediatric and young adult patients taking antidepressants. Exxua is not approved for use in pediatric patients.
- Warnings and precautions associated with Exxua include QT interval prolongation, serotonin syndrome, and activation of mania/hypomania.
- Common adverse reactions include dizziness, nausea, insomnia, abdominal pain, and dyspepsia.
- Exxua is also being studied for the treatment of generalized anxiety disorder (GAD) and hypoactive sexual desire disorder.
Development timeline for Exxua
Further information
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