oral brexanolone (LPCN 1154) / Lipocine - LARVOL DELTA

Lipocine Announces Financial Results for the First Quarter Ended March 31, 2025 (PRNewswire) - "Lipocine has initiated an outpatient Phase 3 safety and efficacy study of LPCN 1154, a non-invasive, rapid onset, oral formulation of brexanolone for the treatment of postpartum depression (PPD). Dosing of the first patient is anticipated in the second quarter of 2025. The Phase 3 study is expected to support a 505(b)(2) New Drug Application (NDA) submission in 2026. Lipocine is exploring the possibility of partnering LPCN 1154 with a third party."

Commercial • FDA filing • Trial status • Postpartum Depression

Lipocine Announces Initiation of Outpatient Phase 3 Postpartum Depression Trial of LPCN 1154 (PRNewswire) - "Lipocine...today announced the initiation of a Phase 3 trial for LPCN 1154 (oral brexanolone) which is in development for the treatment of postpartum depression (PPD)....Based on observed comparable exposure of LPCN 1154 and the reference drug established in the pharmacokinetic (PK) bridge study, the company is initiating a phase 3 safety and efficacy study with expected first patient dosed in the second quarter of 2025."

Trial status • Postpartum Depression

Lipocine Announces Financial Results for the Full Year Ended December 31, 2024 (PRNewswire) - "Based on observed comparable exposure of LPCN 1154 and the reference drug in the PK bridge study, the company is initiating a phase 3 safety and efficacy study with expected first patient dosed in the second quarter of 2025."

New P3 trial • Postpartum Depression

Lipocine Receives Updated Regulatory Guidance on LPCN 1154 (PRNewswire) - "Lipocine Inc...today announced receipt of revised regulatory guidance for LPCN 1154 which the Company is developing for postpartum depression (PPD) treatment. As previously disclosed, the Company was scheduled to meet with the U.S. Food and Drug Administration (FDA or the Division) in Q1 2025 to discuss the NDA submission package of LPCN 1154. Following the meeting, the Company was advised that the Division believes, in addition to the previously completed PK bridge data, an efficacy and safety study of oral LPCN 1154 in the target population will be required for 505(b)(2) NDA submission."

FDA event • Postpartum Depression

"$LPCN Lipocine Announces Favorable Regulatory Pathway on Oral LPCN 1154 for Post-Partum Depression (PPD) https://t.co/moqFr9XlDl" (@stock_titan)

CNS Disorders • Depression • Postpartum Depression • Psychiatry

Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2021 (PRNewswire) - "Research and development expenses were $1.5 million for the second quarter ended June 30 2021...The decrease was primarily due to a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 Phase 2 LiFT clinical study in NASH subjects...These decreases were offset by an increase in costs related to LPCN 1154 and LPCN 1107, as well as increases in other R&D expenses....Research and development expenses were $3.0 million for the six months ended June 30, 2021...The decrease in research and development expenses was primarily due to a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 Phase 2 LiFT clinical study in NASH subjects...These decreases were offset by an increase in costs related to LPCN 1154 and LPCN 1107, as well as increases in other R&D expenses."

Commercial • CNS Disorders • Depression

FDA Clears LPCN 1154 IND Application for a Phase 2 Postpartum Depression Study (Yahoo Finance) - "Lipocine...announced that the U.S. Food and Drug Administration ('FDA') has cleared the Company's Investigational New Drug Application ('IND') to initiate a Phase 2 study to evaluate the therapeutic potential of LPCN 1154, an oral neuro-steroid product candidate, for the treatment of postpartum depression ('PPD') in adults....A pharmacokinetic ('PK') study to assess dose proportionality is planned to start in July 2021 with top-line results expected in the third quarter of 2021. Following the PK study, a proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 1154 in adult female subjects diagnosed with PPD is expected to occur with the first subject dosed in the fourth quarter of 2021."

IND • New P2 trial • New trial • PK/PD data • CNS Disorders • Depression