had filed a new drug application to the U.S. FDA for QuickShot® Testosterone, a drug-device combination offering for the delivery of testosterone enanthate utilizing a subcutaneous auto injector. QuickShot® Testosterone is planned to cure adult men with low testosterone linked with a condition termed as hypogonadism.
The highlights
Robert F. Apple, the CEO and President of Antares, reported that the filing of the QST NDA represents yet another considerable accomplishment for the firm in 2016. It is the initial product planned for subcutaneous distribution of testosterone via a fine gauge needle in subjects diagnosed with hypogonadism.
The management consider QST could be an outstanding treatment alternative for men with hypogonadism. Additionally, to virtually removing the risk of transference that presents with topical gel offerings and the painful deep intramuscular administration linked with existing injectable therapies, the study report showed that the QuickShot auto injector can offer patients with physiologically steady and normal levels of testosterone in the course of therapy.
A possible added advantage to patients is an almost painless treatment involvement as shown by the pain data compiled in Phase III plan. Antares CEO added that they will work thoroughly with the FDA in the regulatory review procedure towards a potential nod with the objective of bringing this new treatment alternative to men identified with hypogonadism.
In the QST phase III plan, the total enrollment count stood at 283. The phase III plan comprised of a 1-year pivotal efficacy and safety study and a subsequent 6-month safety trial. In the phase III plan, patients obtained 75 mg of TE administered through the QuickShot® device administered once in a week for six weeks.
In week 7, blinded dose changes were made if required depending on previous week pre-dose blood levels. The subjects continued to get subcutaneous dosages of 50 mg/ 75 mg/100 mg of testosterone every week for up to 52 weeks. The QST auto injector has to be still approved by the U.S. Food and Drug Administration.
