The drug’s mechanism of targeted single serotonin (5HT) 1a receptor agonism reduced depressive symptoms with an acceptable side effect profile in a trial involving more than 5,000 patients
Fabre-Kramer Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for Exxua (gepirone hydrochloride extended-release tablets) to treat major depressive disorder (MDD) in adults.
Exxua is said to be the first and only antidepressant with a new mechanism of action that selectively targets the serotonin 1A receptor, which is a key regulator of emotion and mood.
Its approved labeling does not have any warnings or adverse reactions about causing sexual dysfunction or weight gain compared to placebo.
The depression medicine is expected to be available in US pharmacies in early 2024.
Fabre-Kramer Pharmaceuticals CEO Stephen Kramer said: “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.”
The drug’s mechanism of targeted single serotonin (5HT) 1a receptor agonism reduced depressive symptoms with an acceptable side effect profile in a trial involving more than 5,000 patients.
As per the study’s results, sexual side effects associated with Exxua therapy were comparable to placebo and did not satisfy the threshold for inclusion in the Adverse Reaction section of the medicine’s label.
Additionally, the MDD drug displayed a generally acceptable safety profile, with no discernible negative effects on liver function, blood pressure, weight, or heart rate.
The most prevalent side effects observed in the studies were nausea and dizziness, both of which were typically mild, transient, related to dose escalation, and did not require treatment withdrawal.
Depression and Bipolar Support Alliance CEO Michael Pollack said: “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 pharmaceutical firm is also developing Exxua for other psychiatric disorders.