Lipocine LPCN 1154 Achieves Bioequivalence to IV Brexanolone in Promising Study Results
Tuesday, 25 June 2024, 12:16
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.
This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.