Conduct Phase III CT: CDSCO panel tells Dr Reddy's Labs after noting Dutasteride linked with AEs like sexual impotence

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.

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