Lipocine (LPCN) Reports Peer-Reviewed Publication of Phase 3 Study Results for TLANDO
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Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the peer-reviewed publication of positive Phase 3 clinical data from the Dosing Validation ("DV") study which evaluated the fixed-dose oral testosterone undecanoate, TLANDO, for the treatment of hypogonadism. As previously disclosed, the DV study met its primary endpoint, with TLANDO restoring testosterone levels to the normal range in hypogonadal males. The paper entitled, "A New Oral Testosterone (TLANDO) Treatment Regimen Without Dose Titration Requirement for Male Hypogonadism," is published in Andrology and can be found online here.
The U.S. Food and Drug Administration ("FDA") previously granted tentative approval to TLANDO in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
"We are pleased by the publication of our positive Phase 3 DV study results," said Dr. Mahesh Patel, Chairman, President, and Chief Executive Officer of Lipocine. "The primary efficacy results confirm that TLANDO administered without dose titration restores testosterone levels to the normal range in hypogonadal men. We believe TLANDO's easy to use and prescribe attributes, no titration requirement and meal flexibility, are preferred by patients and physicians and could be an important differentiated attribute profile for TLANDO, if approved."
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