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Lipocine's Oral Testosterone Drug Fails To Win FDA Panel Backing

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Lipocine Inc.'s (LPCN) New Drug Application for TLANDO has failed to win support from an advisory committee to FDA, with only six members voting in favor and thirteen against the benefit/risk profile of the oral testosterone product candidate. Shares were down 53.47% to $1.61 in extended trading.

TLANDO, formerly known as LPCN 1021, is a twice-a-day oral testosterone product candidate that is designed to help restore normal testosterone levels in hypogonadal men.

Testosterone, often considered as the "fountain of youth", is the major sex hormone in men, and as they age the level of this hormone also naturally declines. The condition in which the body doesn't produce enough testosterone, also known as hypogonadism or simply, Low T, is associated with specific signs and symptoms, including diminished sex drive and sense of vitality, erectile dysfunction, mood disturbances, fatigue and osteoporosis.

Although Low T is especially common in older males, it can also occur at any age, and that can be due to inherited conditions, disease, injury, drugs, and certain types of cancer.

In the U.S., testosterone replacement therapy (TRT) is available in several forms like skin patch, gels, mouth patch, injections and subcutaneous implants. Oral formulations of testosterone are not approved in the U.S. yet, although they are available in Canada, Mexico and Europe.

The FDA decision on whether or not to approve TLANDO is anticipated by the assigned Prescription Drug User Fee Act goal date of May 8, 2018. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

This is TLANDO's second go-around with the FDA. The regulatory agency had turned down this oral testosterone product candidate in June 2016, citing deficiencies related to the dosing algorithm for the proposed label.

Another oral testosterone drug candidate that met the same fate as TLANDO is Jatenzo (formerly Rextoro), developed by privately-held Clarus Therapeutics Inc. On January 9, 2018, the FDA panel voted 10-9 against its approval.

This is the second time that the FDA panel is striking down Jatenzo. In September 2014, the panel members had voted 18-3 that the overall benefit/risk profile of Jatenzo was not acceptable to support approval for testosterone replacement therapy.

by RTTNews Staff Writer

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