Antares Pharma, Inc., a leading developer and marketer of parenteral pharmaceuticals, has dosed its first patient in a clinical study evaluating testosterone enanthate administered weekly by subcutaneous injection at doses of 50 mg and 100 mg via the VIBEX QuickShot auto injector device in testosterone deficient adult males. Up to 45 patients will be enrolled at approximately eight investigative sites in the United States.
Paul K Wotton, Ph.D., president and chief executive officer, stated, “We are very excited about the QuickShot testosterone (QS T) opportunity because we believe it will fill a real need in the growing testosterone replacement market for a convenient self-administered injectable product.”
Dr Wotton continued, “Our proprietary QuickShot device is designed to discreetly administer a fixed dose of testosterone subcutaneously in a matter of seconds. We believe the self-contained QuickShot technology could potentially eliminate transference issues currently seen in the market leading topical testosterone products. The QS T is another example of continued execution of our combination product strategy where we expect to create added value for physicians, patients and shareholders alike.”
The proprietary VIBEX QS device offers a dose capacity of up to 1 ml and the design can be scaled for larger volumes. The device design emphasizes enhanced performance on the attributes most critical to patient success – speed, comfort and discretion. The State-of–the Art engineering accommodates fast injection of highly-viscous drug products such as testosterone that stall lesspowerful conventional auto injectors.
Testosterone deficiency, also known as male hypogonadism or Low T, is a condition in which the body doesn’t produce enough testosterone – the hormone that plays a key role in masculine growth and development during puberty. Some types of male hypogonadism can be treated with testosterone replacement therapy. According to published data, 2012 US sales of testosterone replacement therapies exceeded $2.5 billion dollars with prescriptions on average growing more than 20 per cent annually.