Lipocine LPCN 1154 Achieves Bioequivalence to IV Brexanolone in Promising Study Results
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Lipocine: LPCN 1154 Meets Bioequivalence Criteria in Key Pharmacokinetic Study
Lipocine announces positive topline findings demonstrating the bioequivalence of LPCN 1154 compared to IV brexanolone, a significant milestone in an NDA-enabling pivotal study. The study results highlight the potential of LPCN 1154 in delivering comparable results to IV brexanolone, setting a strong foundation for future regulatory submissions.
Strong Regulatory Milestone
- Positive topline study results confirm bioequivalence of LPCN 1154
- Key step in NDA enabling pivotal study for LPCN 1154
- Preparation for regulatory submissions and potential market approval
The achievement of bioequivalence marks a crucial step towards advancing LPCN 1154 through the regulatory approval process, positioning Lipocine for potential market success.