Conduct PK study for repeated dose and Phase III CT : CDSCO Panel tells Sun Pharma on Psoriatic drug combination

Halobetasol is a corticosteroid that helps relieve redness, itching, swelling, or other discomfort caused by certain skin conditions. Halobetasol Propionate Topical Foam is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Systemic effects of topical corticosteroids may include reversible HPA axis suppression, with the potential for glucocorticosteroid insufficiency.

Tazarotene belongs to a novel, nonisomerizable class of retinoic acid receptor (RAR)-specific retinoids, the acetylenic retinoids, and is the first topical retinoid developed for the treatment of psoriasis.

Tazarotene targets the keratinocyte and modulates the major causes of psoriasis. Tazarotene downregulates markers of keratinocyte differentiation, keratinocyte proliferation, and inflammation. The drug also upregulates three novel genes: TIG-1 (tazarotene-induced gene-1), TIG-2, and TIG-3, which may mediate an antiproliferative effect.

At the recent SEC meeting for Dermatology and Allergy held on March 15, 2023, the expert panel reviewed the proposal presented by the drug major Sun Pharma along with the BE study report and the justification for the Phase III CT study waiver.

After detailed deliberation, the committee recommended:

1. Firm should conduct the PK study for repeated doses.

2. The firm should conduct the Phase III CT study.

In accordance with the above recommendation, the expert panel suggested the firm to present the PK study protocol and Phase III CT study protocol to the Committee for review.

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