EWING, N.J., Dec. 21, 2016 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (ATRS) today announced that it had submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for QuickShot® Testosterone (QST), a drug-device combination product for the delivery of testosterone enanthate using a subcutaneous auto injector. QST is intended to treat adult men with low testosterone associated with a condition known as hypogonadism.
“The submission of the QST New Drug Application represents yet another significant accomplishment for the Company in 2016. It is the first product designed for subcutaneous delivery of testosterone through a fine gauge needle in patients diagnosed with hypogonadism,” said Robert F. Apple, President and Chief Executive Officer. “We believe QST could be an excellent treatment option for men with hypogonadism. In addition to virtually eliminating the risk of transference that exists with topical gel products and the uncomfortable deep intramuscular administration associated with current injectable therapies, the study data demonstrated that the QuickShot auto injector can provide patients with physiologically normal and steady levels of testosterone over the course of therapy. A potential added benefit to patients is a virtually painless treatment experience as demonstrated by the pain data collected in our phase 3 program. We will work closely with the FDA during the regulatory review process towards a potential approval with the goal of bringing this new treatment option to men diagnosed with hypogonadism.”
Two hundred and eighty-three men participated in the QST phase 3 program. The phase 3 program consisted of a one year pivotal safety and efficacy study and a second 6-month safety study. In the phase 3 program, patients received 75 mg of testosterone enanthate (TE) administered via the QuickShot® device once-weekly for 6 weeks. At week 7, blinded dose adjustments were made if necessary based on week 6 pre-dose blood levels. The patients continued to receive subcutaneous doses of 50 mg, 75 mg or 100 mg of testosterone weekly for up to 52 weeks. The QuickShot® testosterone auto injector has not been approved by the United States Food and Drug Administration.
About QuickShot® Testosterone
The investigational subcutaneous testosterone enanthate auto injector is a proprietary, self-administered testosterone replacement option for men diagnosed with hypogonadism that is designed to be injected at home, on a weekly basis. Results from the previously reported Phase 3 pharmacokinetic study showed that testosterone delivered subcutaneously using the QuickShot® testosterone auto injector provided rapid, steady, and reliable efficacy by restoring testosterone to pre-defined physiologic levels.
About QuickShot® Auto Injector
The proprietary QuickShot® auto injector is designed to allow rapid subcutaneous self-administration of highly viscous drugs such as testosterone and biologics using high spring pressure through a fine gauge needle. Conventional auto injectors, or even a vial, needle and syringe could not inject these drugs efficiently or as fast and easy as the QuickShot® device. The QuickShot® auto injector can also provide the patient with the ease and speed of self-administration, comfort and discretion.
About Hypogonadism
Hypogonadism, also known as testosterone deficiency or Low T, is a condition in which the body does not produce enough testosterone – the hormone that plays a key role in masculine growth and development during puberty, and maintenance of musculoskeletal, metabolic, and mental health in maturity. Symptoms of male hypogonadism can be treated with testosterone replacement therapy.
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 third quarter 2016 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. Our 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.
