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May 6, 2014
08:33 EDTATRSAntares Pharma announcse update to QuickShot testosterone program
Antares Pharma announced that a meeting was held with the U.S. Food and Drug Administration to discuss a registration study for the VIBEX QuickShot auto injector in testosterone deficient adult males. The study will include approximately 150 adult males with testosterone blood levels less than 300 ng/dL, and will begin recruitment in the third quarter of 2014. The study is designed to show that once-weekly self-administration of testosterone with the VIBEX QuickShot auto injector can safely achieve normal blood levels of testosterone in hypogonadal men.
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March 4, 2015
09:07 EDTATRSFDA making testosterone product makers change labeling
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February 25, 2015
07:12 EDTATRSAntares Pharma announces QuickShot testosterone study met primary endpoint
Antares Pharma announced positive top-line pharmacokinetic results that showed that the primary endpoint was achieved in the company’s ongoing, multi-center, phase 3 clinical study evaluating the efficacy and safety of testosterone enanthate administered once-weekly by subcutaneous injection using the QuickShot auto injector in testosterone deficient adult males. In the study, 150 adult males with hypogonadism low testosterone and testosterone blood levels less than 300 ng/dL received a starting dose of 75 mg of subcutaneously administered testosterone enanthate once weekly for six weeks. Blinded adjustments to dose were made when necessary at week seven based upon the week six pre-dose blood level, and full pharmacokinetic profiles were obtained during the 12th week of treatment. One hundred fifty patients have received at least one dose of study drug and to date, there have been no reported deaths and one serious adverse event of hospitalization for worsening depression. This patient received a single dose of QS T, and the SAE was not considered to be related to study drug. Thus far, there have been no reported adverse events consistent with urticaria. The FDA has recommended that the company create a larger safety database, including approximately 350 subjects exposed to QS T with 200 subjects exposed for six months and 100 subjects exposed for a year. Based on the number of subjects in previous studies and in the current phase 3 study, the company anticipates that it may need approximately 70 additional subjects exposed to QS T for six months.

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