Lipocine received a third complete response letter from the FDA for its novel oral testosterone replacement therapy Tlando for treatment of male hypogonadism.
In its decision to withhold approval for the third time, the agency noted the drug’s efficacy trial failed to meet secondary endpoints relating to maximal testosterone concentration.
The company received the first CRL for the treatment in June 2016 in which the agency flagged deficiencies in the label’s dosing algorithm. The proposed titration scheme for clinical practice was significantly different from the titration scheme used in its phase 3 trial, “leading to discordance in titration between the…trial and real-world clinical practice,” the agency said.
The second CRL, issued in May 2018, involved four deficiencies, including verification of the maximal testosterone concentration data and appropriate criteria for patients who should discontinue use of the drug.