Lipocine (NASDAQ:LPCN) Receives Updated Regulatory Guidance for LPCN 1154

Salt Lake City, February 6, 2025 – Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on delivering therapeutics through effective oral delivery, announced today that it has received revised regulatory guidance for LPCN 1154. This guidance pertains to the development of LPCN 1154 for the treatment of postpartum depression (PPD). The regulatory update was shared following a meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2025 regarding the New Drug Application (NDA) submission package for LPCN 1154.

The FDA has indicated that in addition to the previously conducted PK bridge data, an efficacy and safety study of oral LPCN 1154 in the target population will be necessary for the 505(b)(2) NDA submission. In response to this guidance, Lipocine is preparing to move forward with a phase 3 safety and efficacy study in line with the regulatory requirements.

Mahesh Patel, CEO of Lipocine, expressed the company’s commitment to providing a fast-acting treatment for postpartum depression. He highlighted that the upcoming study will offer an opportunity to gather valuable safety and depression symptom relief data with LPCN 1154. Patel also mentioned the potential of exploring oral brexanolone for treating anxiety disorders, presenting another promising commercial opportunity with significant unmet needs.

LPCN 1154, an oral formulation of brexanolone, aims to offer rapid relief for postpartum depression. Brexanolone, a positive allosteric modulator of GABA A receptor, is a bioidentical neuroactive steroid. The characteristics of LPCN 1154 are expected to appeal particularly to patients with severe PPD, acute suicide risk, and a need for swift improvement without significant risk to breastfed infants.

Postpartum depression is a form of major depressive disorder that can emerge during pregnancy or within four weeks after delivery. Symptoms may persist for up to a year post-childbirth and are often linked to hormonal changes affecting GABA function. Lipocine’s goal with LPCN 1154 is to address the documented unmet needs in existing PPD treatment options.

Lipocine is actively engaged in advancing its pipeline of differentiated products. In addition to LPCN 1154, the company is developing various drug candidates aimed at addressing significant medical needs, including epilepsy, essential tremor, obesity management, and symptoms associated with liver cirrhosis.

Forward-looking statements in this release are subject to risks and uncertainties, including those associated with product development, regulatory approvals, clinical trials, and market acceptance. Lipocine remains committed to updating stakeholders on any material developments as required by law.

For further information, please visit Lipocine’s website or contact their communications representative.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Lipocine’s 8K filing here.

Lipocine Company Profile

Lipocine Inc, a clinical-stage biopharmaceutical company, engages in the research and development for the delivery of drugs for the treatment of central nervous system (CNS) disorders. Its lead product candidate is TLANDO, an oral testosterone replacement therapy (TRT) comprising testosterone undecanoate.