Antares Pharma (NASDAQ: ATRS) today announced 26-week safety data from the phase 3 study of QuickShot® Testosterone (QST) administered subcutaneously once each week to adult males with hypogonadism. The study, QST-15-005, showed that the most common adverse reactions (incidence ≥5%) were increased hematocrit, upper respiratory tract infection and injection site ecchymosis. The company reports four patients with treatment emergent serious adverse events (SAEs), which included one patient with transient visual impairment determined not to be drug related; one patient with appendicitis that was not drug related; one patient with deep vein thrombosis (DVT), which the investigator attributed DVT as possibly drug related, consistent with known testosterone class SAEs; and one patient with multiple hospitalizations related to septic arthritis and coronary artery disease, with a complicated clinical course post-angioplasty – none of which were deemed drug related. With the completion of this supplemental safety study, the company says it is able to begin the New Drug Application submission process.
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About Antares Pharma
Antares Pharma focuses on self-administered parenteral pharmaceutical products. The Company’s product, OTREXUP™ (methotrexate) injection for subcutaneous use, is approved in the U.S. for the treatment of adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis. The Company and Teva Pharmaceutical Industries, Ltd. (Teva) recently announced the U.S. commercial launch of VIBEX® Sumatriptan Injection USP for the acute treatment of migraine and cluster headache. Antares Pharma is also developing QuickShot® Testosterone for testosterone replacement therapy. The Company’s technology platforms include VIBEX® disposable auto injectors, disposable multi-use pen injectors and reusable needle-free injectors. Antares Pharma has a multi-product deal with Teva that includes VIBEX® epinephrine, exenatide multi-dose pen, and teriparatide multi-dose pen. Its reusable needle-free injector for use with human growth hormone (hGH) is sold worldwide by Ferring B.V. The Company is also working with AMAG Pharmaceuticals on a subcutaneous method of administering Makena, a progesterone product indicated for use in lowering the risk of pre-term birth. For more information, visit www.antarespharma.com
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