The Subject Expert Committee (SEC) under the Central Drug Standard Control Organisation (CDSCO) has recommended that Dr. Reddy’s Laboratories conduct a Phase III clinical trial for Dutasteride, following concerns about its link to adverse events, including sexual impotence. The committee also advised including the International Index of Erectile Function (IIEF) questionnaire in the trial.
This decision followed Dr. Reddy’s submission of safety data for Dutasteride Capsules IP 0.5mg, intended for the additional indication of treating male androgenic alopecia. The safety data was reviewed with the presence of urologists.
Dutasteride, an antiandrogenic compound, is used for treating symptomatic benign prostatic hyperplasia (BPH) in adult males by inhibiting 5-alpha reductase. It blocks both isoforms of the enzyme 5-alpha-reductase, which converts testosterone into dihydrotestosterone (DHT), a key factor in prostate enlargement.
Androgenetic alopecia, characterized by thinning scalp hair, involves the conversion of testosterone to the more potent androgen DHT by 5-alpha-reductase. Dutasteride is a synthetic inhibitor of both type-1 and type-2 isoenzymes of 5-alpha-reductase, and has shown effectiveness in treating androgenetic alopecia in several trials.
At a recent SEC meeting on Dermatology and Allergy, the expert panel reviewed the safety data for Dutasteride’s use in treating male androgenic alopecia. Noting its significant adverse events and a terminal elimination half-life of approximately five weeks at steady state, the committee recommended a Phase III trial, incorporating the IIEF questionnaire.
As reported by Medical Dialogues, the panel suggested that Dr. Reddy’s Labs submit the Phase III study protocol to CDSCO for further review.