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June 25, 2014
07:07 EDTATRSAntares Pharma announces presentation of poster on VIBEX injector
Antares Pharma announced the presentation of a scientific poster at the 16th International Congress of Endocrinology and the Endocrine Society’s 96th Annual Meeting & Expo held in Chicago, Illinois. The poster presents the final pharmacokinetic and safety results from 29 randomized patients treated with a once-weekly injection of testosterone administered subcutaneously with the company’s VIBEX QuickShot auto injector. The company’s previously reported interim results from this multi-center phase 2 clinical study were also presented as a scientific abstract at the same meeting. Results from 29 adult males ages 31 to 69 with hypogonadism symptoms and screening testosterone blood levels less than 300 ng/dl were reported. These patients were randomized into two groups and followed for 10 weeks. The first group received weekly 50 mg testosterone administered subcutaneously with a novel auto injector, and the second group received 100 mg of testosterone using the same device and time sequence. The mean testosterone baseline was 244 ng/dL in the 50 mg group and 243.7ng/dL in the 100 mg group. Testosterone levels normalized within hours of the first dose. At week six of the study when patients were at steady state pharmacokinetic conditions, the 50 mg and 100 mg groups had average plasma testosterone values within the normal range at 422ng/dL and 896 ng/dL, respectively. Rapid restoration, consistent maintenance of normal testosterone levels and dose proportionality of the 50 mg and 100 mg strengths were thereby demonstrated. The once-weekly, virtually pain-free administration took three to four seconds and consistently provided a precise dose of 0.5 ml.
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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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