The US Food and Drug Administration has accepted filing of a new drug application for zuranolone, a neuroactive steroid that targets g-aminobutyric acid type A receptors , for the treatment of major depressive disorder and postpartum depression.
The study included 543 mostly White female patients with MDD. The mean age of the patients was about 40 years. Participants were randomly assigned to receive oral zuranolone 50 mg or placebo once daily for 14 days.The primary endpoint was change in Hamilton Depression Rating Scale score at day 15.The zuranolone group showed significantly greater improvement in depressive symptoms at 15 days compared with the placebo group .
Improvements were observed on day 3, the earliest assessment, and were sustained at all subsequent visits during the treatment and follow-up period .Patients with anxiety who received the active drug experienced improvement in anxiety symptoms compared to the patients who received placebo. The drug was well tolerated, and there were no new safety findings. The most common treatment-emergent adverse events were somnolence and headache. There was no weight gain, sexual dysfunction, withdrawal symptoms, or increased suicidal ideation or behavior.The study adds to evidence suggesting zuranolone is a promising novel therapy for treating MDD, the authors note.The study was conducted by Anita H.