Medical Professionals Reference (MPR)Exxua, a Novel Treatment for Major Depressive Disorder, Gets FDA Approval

New Antidepressant Shows Statistically Significant Improvement in Clinical Trials

In a significant development for the treatment of major depressive disorder (MDD) in adults, the Food and Drug Administration (FDA) has given the green light to Exxua™ (gepirone hydrochloride extended-release tablets). The approval is based on the results of two 8-week, double-blind, placebo-controlled studies, which demonstrated a statistically significant improvement in patients treated with Exxua compared to those on a placebo.

HCN Medical Memo
The approval of Exxua offers a new avenue for treating patients with MDD. Its efficacy, demonstrated through rigorous clinical trials, along with a manageable side effect profile, makes it a promising addition to the treatment landscape. The drug’s Boxed Warning regarding suicidal thoughts and behaviors is an important consideration in patient selection and monitoring.

Key Points

• Exxua works through selective agonist activity at 5HT1A receptors, although its exact mechanism is not fully understood.
• In two 8-week studies involving adults aged 18 to 69 with MDD, Exxua showed a statistically significant improvement in the Hamilton Depression Rating Scale (HAMD-17) total score at week 8.
• Most common adverse reactions include dizziness, nausea, insomnia, abdominal pain, and dyspepsia.
• The drug comes with a Boxed Warning about the risk of suicidal thoughts and behaviors.
• Healthcare professionals comment that the approval of Exxua provides a new option for treating MDD, especially given its comparable side effect profile to placebos in terms of sexual dysfunction and other key metrics.

In the clinical trials for Exxua, the drug showed a placebo-subtracted difference of -2.47 in the HAMD-17 total score, with a 95% confidence interval of -4.41 to -0.53.

Additional Points

• Sexual side effects in Exxua-treated patients were comparable to those in the placebo group, so the labeling does not include sexual dysfunction as an adverse reaction.
• No significant adverse effects were observed in weight, blood pressure, heart rate, or liver function.
• Exxua will be available in various dosage strengths and is expected to hit the market in early 2024.

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