Conduct Phase III CT: CDSCO panel tells Dr Reddy's Labs after noting Dutasteride linked with AEs like sexual impotence
New Delhi: Noting that the drug Dutasteride is associated with significant incidence of adverse events including sexual impotence the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Dr. Reddy’s Labs conduct Phase III clinical trial and include the IIEF (International Index of Erectile Function) questionnaire.
This came after the Dr. Reddy’s Labs submitted the safety data for Dutasteride Capsules IP 0.5mg for the proposed additional indication – “for the treatment of Male Androgenic Alopecia”. The firm presented the safety data in the presence of Urologists.
Dutasteride is an antiandrogenic compound that is used for the treatment of symptomatic benign prostatic hyperplasia (BPH) in adult males by inhibiting 5-alpha reductase.
It is a novel dual 5α-reductase inhibitor that works by blocking both isoforms of 5α-reductase enzymes in a potent, selective, and irreversible manner. Type I and II 5α-reductase enzymes convert testosterone into dihydrotestosterone (DHT), a primary hormonal mediator that plays a role in the development and enlargement of the prostate gland.
Androgenetic alopecia is a common condition characterized by thinning of scalp hair. Conversion of testosterone to dihydrotestosterone, a more potent androgen, by the enzyme 5-α-reductase is responsible for underlying pathogenesis.
Dutasteride, a synthetic 4-azasteroid, is a selective and competitive inhibitor of both type-1 and type-2 isoenzymes of 5-α-reductase. Dutasteride has been demonstrated to be effective in several randomized, double-blind, placebo controlled trials in androgenetic alopecia.
At the recent SEC meeting for Dermatology and Allergy, the expert panel reviewed the safety data for Dutasteride for the proposed additional indication – “for the treatment of Male Androgenic Alopecia” presented by Dr. Reddy’s Labs.
During deliberation, the committee noted that the drug Dutasteride has terminal elimination half-life of approximately 5 weeks at steady state and associated with significant incidence of adverse events including sexual impotence. Therefore, the committee opined that the firm should conduct a Phase III clinical trial and include the IIEF (International Index of Erectile Function) questionnaire.
Accordingly, the expert panel suggested that the firm should submit the Phase III study protocol to CDSCO for further review by the committee.
