- A 150-subject Phase 3 study evaluating the safety and efficacy of testosterone enanthate administered once weekly by subcutaneous injection using Antares Pharma's (ATRS) QuickShot (QST) auto injector in testosterone deficient adult males (<300 ng/dL) achieved its primary endpoint of at least 75% of the patients' mean testosterone levels in the normal range (300 - 1100 ng/dL) at Week 12.
- Study participants will remain on QST and will be followed for an additional 40 weeks.
- On January 13, the company received written recommendations from the FDA pertaining to the clinical development program for QST, some of which are already incorporated into the Phase 3 trial. The agency suggested that it create a larger safety database, including ~350 patients exposed to QST, 200 for six months and 100 for one year. Based on the work done thus far, Antares anticipates that it will need ~70 additional subjects exposed to QST for six months in order to satisfy the FDA's recommendations.
- The value proposition of the QuickShot auto injector the easy, quick and discrete self administration of a consistent dose of medicine.
- Shares are up 12% premarket on higher-than-normal volume.