Antares Pharma (ATRS) Announces Safety Data from QST-15-005 Study

September 22, 2016 7:05 AM EDT

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Antares Pharma, Inc. (Nasdaq: ATRS) announced safety results from the dose-blinded, multiple-dose, concentration-controlled, 26-week phase 3 study of QuickShot Testosterone (QST) administered subcutaneously once each week to adult males with hypogonadism. The study, QST-15-005, included a screening phase, a titration phase and a treatment phase for evaluation of safety and tolerability, including laboratory assessments, adverse events and injection site assessments.

The safety population, defined as patients who received at least one dose of study drug, was comprised of 133 patients. The most common adverse reactions (incidence ≥5%) in this study were increased hematocrit, upper respiratory tract infection and injection site ecchymosis. There were four patients with treatment emergent serious adverse events (SAE’s), which included one patient with transient visual impairment determined not to be drug related, one patient with appendicitis that was not drug related and one patient with deep vein thrombosis (DVT). The investigator attributed DVT as possibly drug related, which is consistent with known testosterone class SAE’s. The fourth patient had multiple hospitalizations related to septic arthritis and coronary artery disease, with a complicated clinical course post-angioplasty. These multiple reported events from the fourth patient were deemed not to be drug related. There have been no reported adverse events consistent with urticaria (hives), POME or anaphylaxis. The safety data collected also included an assessment of pain. Of the 965 injections assessed, pain was reported one time. In that instance, the pain reported was classified as mild.

“We are extremely pleased with the 26-week safety data from study QST-15-005 as well as the previously announced safety data and pharmacokinetic results from study QST-13-003. Our goal has been to produce a safe, convenient and virtually painless treatment alternative to current topical and intramuscular therapies, potentially eliminating both transference issues associated with topical therapies and the peaks and troughs commonly observed with various injectable dosing regimens,” stated Robert F. Apple, President and Chief Executive Officer. “We believe that a once-weekly, subcutaneous dose of QST can restore and maintain steady state testosterone levels consistently, and that the conclusion of this supplemental safety study completes the clinical work necessary to begin the New Drug Application submission process. We will continue to work closely with the Food and Drug Administration toward a potential approval for this unique treatment for hypogonadism.”



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