New Topical Steroid Approved for Plaque Psoriasis

Efficacy was demonstrated in 2 multi-center, randomized, double-blind, vehicle-controlled studies
Efficacy was demonstrated in 2 multi-center, randomized, double-blind, vehicle-controlled studies

Dr. Reddy's announced that Promius Pharma has received approval for Sernivo (betamethasone dipropionate) Spray 0.05%, for the treatment of mild to moderate plaque psoriasis in patients aged ≥18 years. 

Sernivo Spray contains betamethasone dipropionate, a topical steroid. It was evaluated in 2 multi-center, randomized, double-blind, vehicle-controlled studies in patients aged ≥18 years with moderate plaque psoriasis. Patients applied either Sernivo Spray or vehicle spray to the affected area twice daily for 28 days. Efficacy was measured as the proportion of subjects who were considered to have treatment success, defined as an IGA score of 0 or 1 and at least a 2-scale reduction from baseline. 

RELATED: BLA for New Plaque Psoriasis Tx Under FDA Review

Treatment success was obtained in significantly more patients using Sernivo Spray than vehicle spray at Days 15 and 29 for both studies. At Day 29, the Sernivo Spray arm achieved treatment success of 42.7% and 34.5% vs. vehicle arm achieved success rates of 11.7% and 13.6%, respectively (P<0.001).

Sernivo Spray 0.05% is anticipated to launch in the coming quarter. 

For more information call (888) 966-8766 or visit PromiusPharma.com.

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