Lipocine Gets FDA Nod For Mid-Stage Epilepsy Study

The U.S. Food and Drug Administration (FDA) has accepted the Lipocine’s LPCN Investigational New Drug Application (IND) for its candidate, LPCN 2101 in adults with epilepsy. 

The Phase 2 clinical study is designed to evaluate the safety, tolerability, and efficacy of oral LPCN 2101 in photosensitive epilepsy (PSE).

Dr. Mahesh Patel, Chairman, President and CEO, said, "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.”

The company anticipates the initiation of Phase 2 clinical study for Photosensitive Epilepsy in the second half of 2022.

Price action : Lipocine shares are trading around 3 percent higher at $0.81 on Monday at the time of publication.