Antares Pharma Announces Presentations At The Sexual Medicine Society Scientific Annual Meeting


EWING, N.J., Nov. 02, 2016 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) today announced that data from the 52 week phase 3 study of the pharmacokinetics and safety of subcutaneous testosterone enanthate delivered through the QuickShot ® auto injector was selected for an oral podium presentation at the 22 nd Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (SMSNA).  A moderated poster presentation featuring additional data from the same 52 week phase 3 study which tracked psychosexual function in hypogonadal men will also be presented at the same meeting.  Both presentations will be held on November 3, 2016.

Oral Podium Presentation

The abstract, entitled "Safety and efficacy results from the phase 3, double blind, multicenter STEADY trial of a novel, pre-filled, subcutaneous (SC) auto injector for testosterone (T) replacement therapy," was authored by Ronald S. Swerdloff, MD, Los Angeles Biomedical Research Institute and Harbor-UCLA Medical Center, Los Angeles, CA, et al.  The submission was among a select group of key abstracts awarded the prestige of an oral podium presentation.

The dose-blind, multicenter Subcutaneous Testosterone Efficacy and Safety in Adult Men Diagnosed with Hypogonadism (STEADY™) trial of a proprietary, pre-filled auto injector enrolled 150 hypogonadal adult men with baseline testosterone (T) levels of <300 ng/dL.  Patients received 75 mg of testosterone enanthate administered via auto injector once-weekly for 6 weeks. At week 7 blinded dose adjustments were based on week-6, pre-dose blood levels in the patients.  Full pharmacokinetic (PK) profiles were obtained at week 12.

The study's primary endpoint required =75% of patients to achieve average (C avg) serum testosterone levels within the normal range of 300 to 1,100 ng/dL, with a lower limit of a 95% 2-sided confidence interval (CI) =65%. Additionally, =85% of week-12 serum maximum (C max) values of <1500 ng/dL and no more than 5% of C max values of >1,800 ng/dL were required. Patients without a C max determination at week 12 due to dropping out of the study were assigned to the above 1,500 ng/dL group.

In the intent to treat analysis, at week 12, C avg was within the 300 to 1100 ng/dL range in 139 out of the patients enrolled (92.7%), with 95% CI lower limit of 87.3%.  C max was <1500 ng/dL in 137 out of 150 patients (91.3%).  In addition, one-hundred thirty-seven patients completed all study procedures at 12 weeks.  Among the completers at week 12,  C avg was within the 300 to 1100 ng/dL range in 135 out of 137 patients (98.5%) with 95% CI lower limit of 94.8% and C max was <1500 ng/dL in 137 patients (100%). Patients achieved a mean (± standard deviation) steady-state T concentration of 553.3 ± 127.3 ng/dL at 12 weeks.

The details for Dr. Swerdloff's podium presentation are as follows:

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