Efficacy, Safety, and Potency of Betamethasone Dipropionate Spray 0.05%: A Treatment for Adults with Mild-to-moderate Plaque Psoriasis

Abstract

Objective: A spray formulation of betamethasone dipropionate 0.05% (BD spray 0.05%; Sernivo™ [betamethasone dipropionate] Spray 0.05%; Promius Pharma, LLC; Princeton, New Jersey, USA) has been developed for the topical treatment of psoriasis. The objective of these studies was to evaluate the efficacy, safety, and potency of BD spray 0.05%. Design, Setting, Participants, and Measurements: Efficacy and safety were assessed in a randomized, vehicle-controlled, double-blind study in adults with moderate plaque psoriasis (ClinicalTrials.gov identifier: NCT01947491). Additionally, the potential for adrenal suppression and systemic absorption was evaluated in a randomized, open-label study in healthy adults (ClinicalTrials.gov identifier: NCT02070965). Potency was measured in two single-point, randomized, evaluator-blinded studies in healthy adults. Results: BD spray 0.05% was significantly more effective than the vehicle spray in subjects with moderate plaque psoriasis after three, 14, and 28 days of twice-daily treatment. The efficacy of BD spray 0.05% was similar to augmented BD lotion 0.05% after 14 days of treatment. The safety of BD spray 0.05% was similar to that of the vehicle spray over 28 days and to that of augmented BD lotion 0.05% over 14 days. Under maximal use conditions for up to 29 days, the potential for adrenal suppression was no greater with BD spray 0.05% than with a 15-day regimen of augmented BD lotion 0.05%. There was less systemic absorption of BD from BD spray 0.05% than from augmented BD lotion 0.05%. Studies classify BD spray 0.05% as a midpotent corticosteroid. Conclusions: BD spray 0.05%, a midpotent corticosteroid, is an effective and well-tolerated treatment for adults with mild to moderate plaque psoriasis.

Keywords: Psoriasis; betamethasone dipropionate; corticosteroid; topical.

Conflict of interest statement

FUNDING:This study was funded and sponsored by the Dr. Reddy’s Laboratories group of companies in Princeton, New Jersey, USA DISCLOSURES:Drs. Sidgiddi, Pakunlu, and Allenby are employees of Dr. Reddy’s Laboratories, whose subsidiary, Promius Pharma, LLC, markets the topical formulation of betamethasone dipropionate spray, 0.05% (Sernivo™), the product used in this study. Drs. Sidgiddi and Allenby own stock in Dr. Reddy’s Laboratories.

Figures

FIGURE 1.

Percentage of subjects with treatment successain the efficacy and safety study (n=394)—aIGA of 0 or 1 with at least a 2-grade reduction; bonly administered through Day 14 per approved labeling

FIGURE 2.

Percentage of subjects with ≥50% reduction in TSS in the efficacy and safety study (n = 394)—aOnly administered through Day 14 per approved labeling