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news.Lipocine has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its LPCN 1021 oral testosterone replacement product candidate.
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The twice-a-day product can be used in adult males for conditions related with a deficiency or absence of endogenous testosterone (hypogonadism).
The company’s oral androgen replacement (SOAR) pivotal Phase 3 clinical study identified efficacy and safety of LPCN 1021 in hypogonadal men with low testosterone.
Testosterone levels were restored to the normal range in 88% of the subjects and 85% of them reached their final dose with single dose titration.
The company said LPCN 1021 treatment was well tolerated with no hepatic, cardiac, gastrointestinal or drug associated serious adverse events.
Lipocine chairman, president and CEO Mahesh Patel said: "Filing of the NDA for LPCN 1021 is a significant achievement for Lipocine and a major milestone toward bringing this potential testosterone replacement therapy option to patients.
"LPCN 1021 has the potential both to improve the ease of use compared to the available formulations, including topical gels and injections, and to overcome inadvertent testosterone transference risk to children and partners.
"We look forward to working closely with the FDA during the review process."