The Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) met on January 9th and 10th to discuss two potential oral testosterone formulations.
The Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) met on January 9th and 10th to discuss two potential oral testosterone formulations: Jatenzo (Clarus Therapeutics) and Tlando (Lipocine). Both formulations are the first proposed oral testosterone replacement therapy for males with conditions associated with a deficiency or absence of testosterone, such as congenital/acquired primary hypogonadism and hypogonadotropic hypogonadism.
Both drugs contain the testosterone prodrug T undecanoate (TU), which is absorbed through the intestinal lymphatic system. After TU is absorbed, enzymes elicit the release of testosterone from the prodrug. Both Clarus and Lipocine demonstrated that the oral route of administration increases the bioavailability of testosterone, compared to the currently available topical and injectable options.
Clarus and Lipocine highlighted several benefits to their oral treatments which included; convenient dosing regimens, avoiding inadvertent testosterone exposure to other individuals (children/women), and increased patient compliance.
The panel members expressed concern over the increased access, which could have the potential to expose millions to unnecessary risk. Additionally, the panel members voiced concerns over the potential for cardiovascular side effects and study conduct. This resulted in a 10-9 vote against approval of Jatenzo and a 13-6 vote against approval of Tlando. Several panel members agreed that the sponsors need to develop robust Risk Evaluation and Mitigation Strategy (REMS) programs for their products, particularly limiting off-label use. Panel members noted the Aveed product (an injectable TU for hypogonadism) by Endo Pharmaceuticals, which is currently available through a restricted distribution program.
Interestingly, this is the second attempt at approval for both drugs. Lipocine’s Tlando was originally denied approval in 2015, due to concerns over how testosterone levels were measured in their clinical study. Jatenzo, formerly Rextoro, was denied approval in 2014 due to a negative opinion of the drug’s benefit-risk profile.
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