Fabre-Kramer Pharmaceuticals has obtained approval from the US Food and Drug Administration (FDA) for Exxua (gepirone hydrochloride extended-release tablets) to treat major depressive disorder (MDD) in adult patients.
Exxua is the first and only approved antidepressant with a new action mechanism that selectively acts on the serotonin 1A receptor, a crucial mood and emotion regulator.
The company plans to make the oral selective serotonin (5HT) 1a receptor agonist Exxua available in pharmacies from the start of 2024.
Exxua, which was studied in more than 5,000 patients, reduces depressive symptoms with an acceptable side-effect profile.
Sexual side effects observed during clinical trials of Exxua were comparable to those reported in the placebo and did not meet the criteria for inclusion in the adverse reaction section of its label.
There was no significant adverse effect on blood pressure, heart rate, weight or liver function and the therapy demonstrated an overall acceptable safety profile.
Fabre-Kramer CEO Stephen Kramer stated: “Exxua represents an important milestone in the treatment of MDD, a serious and debilitating condition that affects millions of people worldwide.
“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.”
Exxua is also in development for other psychiatric disorders.
Fabre-Kramer is focused on the development and commercialisation of new medications for neurology and psychiatry disorders.