FDA issues Complete Response Letter for Tlando, a proposed testosterone replacement therapy .- Lipocine Inc.
Lipocine Inc. has announced that it has received a Complete Response Letter from the FDA regarding its New Drug Application for Tlando, the Company's oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. A CRL is a communication from the FDA that informs companies that an application cannot be approved in its present form.
The CRL identified four deficiencies which include the following: determining the extent, if any, of ex vivo conversion of testosterone undecanoate ("TU") to testosterone ("T") in serum blood collection tubes to confirm the reliability of T data; obtaining definitive evidence pre-approval via an ambulatory blood pressure monitoring study as to whether Tlando causes a clinically meaningful increase in blood pressure in hypogonadal men; verifying the reliability of Cmax data and providing justification for non-applicability of the agreed-upon and prespecified Cmax secondary endpoints for Tlando; and, determining the appropriate stopping criteria that can reproducibly and accurately identify those patients who should discontinue use of Tlando. The CRL also identified additional comments that are not considered approvability issues. The next step will be to request a meeting with the FDA to further evaluate the deficiencies raised and to agree upon a path forward for a potential approval of Tlando.
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