Lipocine Doses First Participant in P-III (BLOOM) Study of LPCN 1154 for Postpartum Depression

Shots: Lipocine has dosed the first participant in the placebo-controlled outpatient P-III (BLOOM) study evaluating LPCN 1154 (oral brexanolone) as a 48hrs. at-home treatment in ~120 pts with postpartum depression (PPD) The study will assess the same 48hrs. regimen & 1EP as the prior P-III trial, i.e., change from baseline in HAM-D17 total score at 60hrs., with added site-selection, placebo-response & data-quality measures based on FDA feedback Topline results are expected in H2’27 and are intended to support a potential 505(b)(2) NDA; the prior P-III trial did not meet its 1EP in the full analysis set Ref: Lipocine  |   Image: Lipocine  |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post Lipocine Doses First Participant in P-III (BLOOM) Study of LPCN 1154 for Postpartum Depression appeared first on PharmaShots.