QuickShot Testosterone filed with FDA for testosterone deficiency- Antares Pharma
Antares Pharma has announced that it had submitted a New Drug Application (NDA) to the 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.
Two hundred and eighty-three men participated in the QST phase III program. The phase III program consisted of a one year pivotal safety and efficacy study and a second 6-month safety study. In the phase III 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.
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