FDA approves Lipocine’s IND for adult epilepsy treatment

pharmafile | July 12, 2022 | News story | Manufacturing and Production  

The FDA has accepted Lipocine’s Investigational New Drug Application (IND) for its neuroactive steroid (NAS) candidate, LPCN 2101, as a potential treatment for adults with epilepsy.

Lipocine now intends to start a Phase II photosensitive epilepsy study, to evaluate the safety, tolerability, and efficacy of oral LPCN 2101.

LPCN 2101 is an orally administered, endogenous neuroactive steroid (NAS), a positive allosteric modulator (PAM) of GABA receptor, with potential therapeutic effects in neurological and mood disorders. There were no concerning safety and tolerability signals observed in preclinical studies, and a favourable pharmacokinetic profile was demonstrated.

Epilepsy is a brain disorder causing intense seizures, and it is estimated that roughly 900,000 women of childbearing age suffer from it in the US. This causes significant challenges to women, due to the often debilitating seizures it can cause, as well as hormonal fluctuations and coexisting mood disorders.

There is currently a high unmet need for an anti-seizure medication with no to low foetal-neonatal toxicity, as well as potential to treat associated psychiatric comorbidities.

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.”

Lina Adams

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