The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Lipocine regarding the New Drug Application for Tlando (testosterone undecanoate), an oral testosterone product candidate for testosterone replacement therapy in adult males with primary hypogonadism or hypogonadotropic hypogonadism.

In the CRL, the Agency noted that the trial establishing the efficacy of the investigational product did not meet the 3 secondary end points for maximal testosterone concentrations. According to the FDA, trials for testosterone therapies have 3 standard secondary end points to assess for unacceptably high maximal exposures to testosterone that could potentially raise safety concerns.

“We are disappointed by the FDA’s decision and intend to request a meeting with the FDA as soon as possible to discuss a potential path forward for the approval of Tlando,” said Dr Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine.

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This is the second time the Company has received a CRL from the FDA. In May 2018, following an unfavorable vote by the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee,” the Agency identified 4 deficiencies, one of which included “verifying the reliability of Cmax data and providing justification for non-applicability of the agreed-upon and prespecified Cmax secondary end points for Tlando.”


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