Clarus seeks FDA approval for oral testosterone

Low T1 Clarus seeks FDA approval for oral testosterone Biotech firm Clarus Therapeutics resubmitted its New Drug Application (NDA) for Jatenzo, an oral version of testosterone, hoping the drug will become the first oral testosterone product on the market.

Clarus has been in a head-to-head race with Lipocine Inc.’s LPCN 1021 to gain Food and Drug Administration (FDA) approval for an oral testosterone treatment. Lipocine’s bid for FDA clearance was shot down in early 2016 after regulators questioned the dosing algorithm. The company responded by submitting a new dosing validation study protocol, which the FDA reviewed and approved. That study is currently underway.

The NDA for Jatenzo was initially submitted in early 2014 under the name Rextoro, but was ultimately rejected by an FDA advisory panel over safety and efficacy concerns.

Testosterone replacement products come in a variety of forms including injections, gels, nasal sprays and transdermal patches. An oral version would offer more convenience to patients, the drug companies say.

Testosterone treatments, like LPCN 1021 and Jatenzo, are intended for men with hypogonadism, a condition in which men do not produce enough testosterone due to a defect or disease. It is not intended for men with age-related hypogonadism, though testosterone manufacturers have heavily marketed the medication directly to consumers.

Manufacturers of testosterone treatments face thousands of lawsuits over testosterone side effects. Those suing testosterone manufacturers like AndroGel maker AbbVie Inc. claim the drug companies did not adequately warn that use of the hormone treatment could increase their risk of heart attacks, strokes, blood clots and death.

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