Phase III trial of QuickShot auto injector (testosterone enanthate) shows efficacy in testosterone deficient adults- Antares Pharma

Antares Pharma announced 12 week efficacy and 52 week safety results from the phase III clinical study (QST-13-003) evaluating testosterone enanthate administered once-weekly by subcutaneous injection using the QuickShot auto injector in testosterone deficient adult males. In the 12 week study, as previously disclosed, the trial met all of the primary endpoints.

For the 52 week safety study, the most common adverse reactions (incidence more than 5%) in this Phase III study were increased hematocrit, hypertension, increased PsA, Upper Respiratory Tract Infection, sinusitis, injection site bruising and headache. Serious adverse events (SAE’s) reported included one case each of worsening depression, vertigo and suicide. All of the SAE’s were not considered to be related to study drug by the investigators, however the Company determined that the case of suicide could not be ruled out as potentially being related to study drug.

There have been no reported adverse events consistent with urticaria (hives), POME, anaphylaxis or major adverse cardiovascular events in this study. The safety data collected included an assessment of pain. When pain was reported its intensity was recorded using a 10-point pain scale, with a score of 1 described as barely noticeable and 10 as the worst pain experienced. Of 1519 injections assessed, pain was reported 9 times. In these 9 instances, the pain intensity was reported as either a 1 or a 2, with an average score of 1.3.