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Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced the resubmission of a New Drug Application (NDA) for LPCN 1021, its oral testosterone product candidate for testosterone replacement therapy (TRT) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

Lipocine had previously submitted an NDA for LPCN 1021 and received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in June 2016. The CRL identified a deficiency related to the dosing algorithm for the proposed label. With the goal of addressing this deficiency, the company successfully completed a dosing validation (DV) study, which confirmed the validity of a fixed dose approach without the need for dose titration to orally administer LPCN 1021. The efficacy results of the DV study, as well as an integrated safety set (ISS) from all previously conducted clinical trials, including 52-week safety results from the Phase 3 Study of Androgen Replacement (SOAR) clinical study, form the basis for the NDA resubmission.

Resubmission of this NDA as planned is an important milestone in bringing LPCN 1021 to patients, said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. We believe the results from the recently completed DV study address the label-related deficiency identified by the FDA in the CRL. We consider LPCN 1021 to be a differentiated TRT option for treating hypogonadism in men. We anticipate a six-month review by the FDA with a projected PDUFA date in the first quarter of 2018 assuming the FDA acknowledges our submission is a complete response.

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Lipocine (LPCN) Resubmits NDA for Oral Testosterone Product Candidate, LPCN 1021, for Treatment of Hypogonadism - StreetInsider.com

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