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Testosterone therapy shows promise
November 2016
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SALT LAKE CITY—Lipocine Inc. had promising results to share recently regarding its Phase 2b clinical study of LPCN 1111, a novel oral testosterone replacement therapy product candidate. The study’s primary objectives were to determine the Phase 3 dose for the compound as well as the safety and tolerability of LPCN 1111 and its metabolites when administered orally in single and multiple doses to hypogonadal males. The results of the pharmacokinetic study suggest that the primary objectives were met, with a good dose-response relationship observed. Primary and secondary endpoints were met by the target Phase 3 dose, and LPCN 1111 was well tolerated with no drug-related severe or serious adverse events.
 
“We are pleased to report these positive top-line results, as these results reinforce our belief that LPCN 1111 represents a promising product candidate for once daily administration of testosterone,” said Dr. Mahesh Patel, president and CEO of Lipocine. “Based on this progress, we plan to meet with the United States Food and Drug Administration to discuss Phase 3 development plans.”

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