New Delhi: Rejecting the drug major Sun Pharma’s proposal for a Phase III clinical trial study waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that the firm should conduct the pharmacokinetic (PK) study for repeated dose and the Phase III clinical trial of the fixed-dose combination Halobetasol propionate plus Tazarotene topical lotion.
This came after the drug major Sun Pharma presented its proposal before the committee along with a bioequivalence (BE) study report that was conducted for export purposes as well as justification for Phase III CT study waiver.
Fixed-dose combination Halobetasol propionate plus Tazarotene topical lotion is used topically to treat plaque psoriasis. Plaque psoriasis is a skin disease with red patches and white scales that do not go away.
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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