Lipocine Inc. announced that the FDA has accepted the company's Investigational New Drug Application ("IND") for its neuroactive steroid ("NAS") candidate, LPCN 2101, as a potential treatment for adults with epilepsy. Lipocine plans to initiate a Phase 2 photosensitive epilepsy ("PSE") study to evaluate the safety, tolerability, and efficacy of oral LPCN 2101.
Dr. Mahesh Patel, Chairman, President and CEO of Lipocine Inc. commented, "We are excited to advance further testing of LPCN 2101. We believe it has the potential to address the unmet medical needs in epilepsy management as well as mood disorders comorbidities, particularly in women of childbearing age. We look forward to initiating the planned proof-of concept study."
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