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

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Go back to Lipocine (LPCN) Announces Favorable Regulatory Pathway on Oral LPCN 1154

Lipocine Announces Favorable Regulatory Pathway on Oral LPCN 1154 for Post-Partum Depression (PPD)

September 15, 2022 8:00 AM EDT

FDA agrees with Lipocine establishing LPCN 1154 pathway to efficacy through a pharmacokinetic (PK) bridge to an approved IV infusion brexanoloneLipocine has demonstrated that the brexanolone exposure of LPCN 1154 is similar to the levels observed in third trimester pregnant women samplesA 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... More