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.

FIGURE 1.

Percentage of subjects with treatment success^ain 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