Shots:

• The approval is based on P-III inTUNE clinical trial assessing Jatenzo vs Axiron in 222 patients in ratio (3:1) for patients with hypogonadal male in adults
• The study resulted: met 1EP as 87.3% of patients and the lower bound of the 95% confidence interval 81.3% met the FDA targets of ≥ 75% and ≥ 65% respectively- consistent with two earlier P-III data
• Jatenzo is a softgel oral formulation of testosterone undecanoate for testosterone replacement therapy in certain adults available in three dosage form 158 mg- 198 mg and 237 mg administered twice daily with its expected marketing in H2’19

Click here to read full press release/ article | Ref: Clarus Therapeutics | Image: Twitter