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Antares Pharma, Inc.
ATRS today announced that the last patient has completed treatment in the dose-blinded, multiple-dose 52 week Phase 3 study to evaluate the efficacy and safety of QuickShot® Testosterone (QS T) administered subcutaneously once each week to adult males with hypogonadism.
"We are very excited to announce that the last patient has completed week 52 in our Phase 3 study in testosterone deficient adult males," stated Eamonn P. Hobbs, President and Chief Executive Officer. "Once the 26 week supplemental safety study currently underway has concluded, we will combine the previously announced positive pharmacokinetic data and safety portion of this study into our New Drug Application and plan to work closely with the Food and Drug Administration toward a potential approval." Approximately 150 patients were enrolled in this multicenter dose-blinded, multiple-dose study. Patients meeting all eligibility criteria were assigned to receive 75 mg of QS T once weekly for six weeks. Adjustment to dose, if needed, was made at week seven based upon the week six Ctrough value. Additional strengths of 100 mg and 50 mg were utilized in dose titration. Patients were dosed for
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