Lipocine announces favorable regulatory pathway on oral lpcn 1154 for post-partum depression (ppd)

Fda agrees with lipocine establishing lpcn 1154 pathway to efficacy through a pharmacokinetic (pk) bridge to an approved iv infusion brexanolone lipocine has demonstrated that the brexanolone exposure of lpcn 1154 is similar to the levels observed in third trimester pregnant women samples a pilot pk bridge study is planned with results expected in 1q 2023 salt lake city , sept. 15, 2022 /prnewswire/ -- 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.
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