Repros Reports Preliminary Findings: Second Pivotal Study and 6-Month Safety Study Support Androxal(R) Approvability
- Androxal meets both co-primary endpoints in second pivotal study ZA-302
- Testosterone normalized in 81% of patients
- No deleterious effects on sperm function
- No excursions above normal in 24 hour average testosterone
- Androxal is generally well tolerated in 6 month safety study ZA-300
- No dose dependent adverse events
- Adverse event profile similar or superior to other approved testosterone therapies with over 90% of safety database collected
- NDA submission on track
Repros Therapeutics Inc.(R) (RPRX) today reported topline results from both the second pivotal efficacy study as well as the 6 month safety study of Androxal(R) in the treatment of men with secondary hypogonadism.
- Published: 17 September 2013
- Written by Editor