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FDA Wants More Safety Data on Testosterone Drug

Hives reported in mid-stage trial

The FDA has asked for additional safety data on the testosterone drug QuickShot Testosterone (QST, Antares Pharma).

Based on the reported occurrence of hives in a phase II study, which the FDA characterized as an apparent allergic reaction, as well as on the known safety experience with other parenteral testosterone products, the FDA recommended that Antares create a larger safety database, including approximately 350 subjects exposed to QST, with 200 subjects exposed for 6 months and 100 subjects exposed for 12 months.

Antares believes that it has already factored many of the recommendations cited in the FDA’s advice letter into the protocol of an ongoing phase III study of QST and into the protocols for planned human use studies as a result of guidance provided by the agency at a May 2014 meeting.

Antares has also stated that it does not believe that the adverse event of hives reported in the phase II trial was related to the study drug. Based on the number of subjects in previous studies and in the current phase III trial, the company anticipates that it may need approximately 70 additional subjects exposed to QST for 6 months.

Antares is assessing the FDA’s comments in its advice letter and their effect on the filing of a new drug application for QST. The timing, cost, and design of the study to obtain the additional 70 subjects and the data required will be determined based on further discussion with the FDA. Antares expects to release top-line pharmacokinetic data from the current phase III study in the second quarter of 2015.

The FDA has become more cautious about approving testosterone drugs after it found late last year that more than one-fifth of the patients prescribed such drugs did not get their testosterone levels tested before or during treatment.

Sources: Antares Pharma Inc.; January 13, 2015; and Reuters; January 13, 2015.

 

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