Lipocine (LPCN) Announces Favorable Regulatory Pathway on Oral LPCN 1154

Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on developing innovative products targeting large addressable markets with significant unmet needs to treat central nervous system ("CNS") and metabolic disorders, announced today that the U.S. Food and Drug Administration ("FDA") has agreed with Lipocine's proposal for establishing the efficacy of LPCN 1154 through a single pivotal pharmacokinetic ("PK") bridge to an approved IV infusion brexanolone via a 505(b)(2) NDA filing. Lipocine plans additional work in parallel to pursue a well differentiated label.

LPCN 1154 is an oral neuroactive steroid being developed for the treatment of PPD. It is a non-invasive oral product candidate comprised of brexanolone, an endogenous positive allosteric modulator of γ-aminobutyric acid ("GABA") receptor. Lipocine has demonstrated that the brexanolone exposure of LPCN 1154 is similar to the levels observed in third trimester pregnant women samples. These results represent the first enablement of potentially efficacious oral brexanolone for PPD.

"We are truly excited about the encouraging FDA pathway feedback and oral enablement of brexanolone through leveraging of our proprietary Lip'ral technology platform," said Dr. Mahesh Patel, President and CEO of Lipocine Inc. "If approved, LPCN 1154 is expected to be the fastest acting oral option for PPD with potential for out-patient use."

Lipocine plans to initiate a pilot PK bridge study of LPCN 1154 and an FDA approved IV infusion brexanolone in 4Q 2022, with results expected in 1Q 2023.

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