FDA OKs novel treatment for depression

Gepirone (Exxua) is indicated for treatment of major depressive disorder in adults. While the mechanism of antidepressant effect isn't fully understood, it's thought to be related to selective agonist activity at 5HT1A receptors. Approval was based on data from two, eight-week RCTs in which patients in the gepirone groups experienced statistically significantly greater improvement in HAMD-17 scores at week 8, compared with placebo. The drug label includes a boxed warning regarding suicidal thoughts and behaviors.