Improvements in Depression and Anxiety Symptoms in Patients with Severe Postpartum Depression (PPD) Treated With BRII-296
Background: PPD is a potentially severe mood disorder that affects 1 in 7 women within the first year after childbirth. BRII-296 is an extended-release intramuscular (IM) injectable brexanolone that aims to provide clinically meaningful advantages in the treatment of PPD due to its formulation and route of administration.
Methods: Multicenter open-label, single-arm study of safety, tolerability, pharmacokinetics, and descriptive efficacy of 600 mg BRII-296 IM injection in adults with severe PPD. Women (Nf11) ages 18-45, ≤12-months postpartum with PPD and HAMD-17 ≥24 were followed for 45 days after receiving a 1-time dose via 2 IM injections of 300 mg BRII-296 admixed with 40 mg methylprednisolone acetate per injection in each gluteus medius muscle.
Results: Patients experienced continuous improvement of depression and anxiety symptoms at all time points to Day 45 (change from baseline HAMD-17 of -25.3±4.05; HAM-A of -25.6±8.74 at Day 45). Similar improvements in depression symptoms were observed with EPDS (-20.5±3.11 change from baseline at Day 45). Single treatment with 600 mg BRII-296 IM injection demonstrated sustained release and long-acting concentrations of brexanolone maintained for up to 7 days. All AEs were mild or moderate in severity. Injections were well tolerated. There were no clinically significant findings in vital signs (including orthostatic hypotension), pulse oximetry, clinical labs, or ECGs.
Conclusions: Single administration of BRII-296 was safe and well tolerated with steady improvements and maintenance of clinical benefits in depressive and anxious symptoms of PPD throughout the 45-day observation period without reports of relapse or worsening of clinical condition.
