Lipocine announced that its Phase 3 trial for LPCN 1154, an oral formulation of brexanolone for postpartum depression, failed to demonstrate efficacy. The Utah-based biotechnology company's stock plummeted 77% following the announcement.
LPCN 1154 was designed as an oral alternative to Sage Therapeutics' IV-administered brexanolone (Zulresso), which is currently approved for postpartum depression but requires costly inpatient monitoring. An effective oral version could have significantly expanded treatment accessibility for women suffering from this condition.