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Lipocine Says FDA Oks LPCN 2101 IND For Adult Epilepsy Treatment
(RTTNews) - Biopharmaceutical company Lipocine Inc. (LPCN) announced Monday that the U.S. Food and Drug Administration (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.
LPCN 2101 is an orally delivered, endogenous neuroactive steroid (NAS), a positive allosteric modulator (PAM) of GABAA receptor, with potential therapeutic effects in neurological and mood disorders.
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