FDA accepts NDA for oral testosterone softgel for male hypogonadism
The FDA accepted a new drug application for an oral testosterone undecanoate softgel for the treatment of primary and secondary hypogonadism in men, according to a press release from Marius Pharmaceuticals.
The submission of testosterone undecanoate (Kyzatrex) is supported by comprehensive data from the ReTUNE study, a multicenter 12-month trial among men with hypogonadism (total testosterone 281 ng/dL). The primary outcome was the number of participants with testosterone in the normal range at 90 days. Safety was assessed during 9 months of follow-up. Participant-reported outcomes indicated statistically significant improvement from baseline, according to the release. In a 6-month phase 3 safety trial, participants received an improved dose regimen and were monitored through ambulatory blood pressure monitoring. Results will be published in medical journals at presented at national conference later this year, according to the release.
The FDA has set a PDUFA target date of Oct. 31. The company said in the release it plans to launch the product immediately if approved.