Antares Pharma announced the submission of a New Drug Application (NDA) for QuickShot Testosterone (testosterone enanthate auto-injector) to the Food and Drug Administration (FDA) to treat males with low testosterone associated with hypogonadism.
QuickShot Testosterone is a drug-device combination that delivers testosterone enanthate via a subcutaneous (SC) auto-injector. This route of administration removes the risk of transference that is seen with topical gels and deep intramuscular (IM) injections that are currently available. The QuickShot proprietary auto-injector is intended to allow rapid SC self-administration of highly viscous drugs (eg, testosterone, biologics) using high spring pressure through a fine gauge needle.
The Phase 3 program for QuickShot Testosterone enrolled 283 adult males and consisted of a 1-year pivotal safety and efficacy study and a 6-month safety study. Patients were administered testosterone enanthate 75mg via the QuickShot device once weekly for 6 weeks. Blinded dose adjustments were made at Week 7 based on pre-dose blood levels from Week 6. Patients were then continued on SC 50mg, 75mg or 100mg testosterone weekly for up to 52 weeks.
Pharmacokinetic study data showed that the use of QuickShot Testosterone auto-injector resulted in rapid, physiologically normal and steady concentrations of testosterone over the course of therapy. Pain data that was obtained through the program also demonstrated that QuickShot Testosterone was a “virtually painless treatment experience.”