A new prescription topical steroid has received FDA approval for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. Betamethasone dipropionate (Sernivo) Spray, 0.05%, from Promius Pharma, LLC, US, a subsidiary of Dr. Reddy’s, will be available next quarter.
The company conducted 2 multi-center, randomized, double-blind, vehicle-controlled clinical trials in subjects aged 18 years and older with moderate plaque psoriasis to evaluate the safety and efficacy of the spray. In both trials, randomized subjects applied betamethasone dipropionate spray, 0.05%, or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10% to 20%, and an Investigator Global Assessment (IGA) score of 3 (moderate). Efficacy was assessed as the proportion of subjects who were considered a treatment success (defined as having an IGA score of 0 or 1 [clear or almost clear] and at least a 2-scale reduction from baseline). Treatment success was achieved in significantly more subjects using betamethasone dipropionate spray, 0.05%, than vehicle at both Day 15 and Day 29 across both studies. At Day 29 in Studies 1 and 2, betamethasone dipropionate spray, 0.05%, achieved treatment success of 42.7% and 34.5% compared to vehicle success rates of 11.7% and 13.6%, respectively (P<0.001).
A new prescription topical steroid has received FDA approval for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. Betamethasone dipropionate (Sernivo) Spray, 0.05%, from Promius Pharma, LLC, US, a subsidiary of Dr. Reddy’s, will be available next quarter.
The company conducted 2 multi-center, randomized, double-blind, vehicle-controlled clinical trials in subjects aged 18 years and older with moderate plaque psoriasis to evaluate the safety and efficacy of the spray. In both trials, randomized subjects applied betamethasone dipropionate spray, 0.05%, or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10% to 20%, and an Investigator Global Assessment (IGA) score of 3 (moderate). Efficacy was assessed as the proportion of subjects who were considered a treatment success (defined as having an IGA score of 0 or 1 [clear or almost clear] and at least a 2-scale reduction from baseline). Treatment success was achieved in significantly more subjects using betamethasone dipropionate spray, 0.05%, than vehicle at both Day 15 and Day 29 across both studies. At Day 29 in Studies 1 and 2, betamethasone dipropionate spray, 0.05%, achieved treatment success of 42.7% and 34.5% compared to vehicle success rates of 11.7% and 13.6%, respectively (P<0.001).
A new prescription topical steroid has received FDA approval for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. Betamethasone dipropionate (Sernivo) Spray, 0.05%, from Promius Pharma, LLC, US, a subsidiary of Dr. Reddy’s, will be available next quarter.
The company conducted 2 multi-center, randomized, double-blind, vehicle-controlled clinical trials in subjects aged 18 years and older with moderate plaque psoriasis to evaluate the safety and efficacy of the spray. In both trials, randomized subjects applied betamethasone dipropionate spray, 0.05%, or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10% to 20%, and an Investigator Global Assessment (IGA) score of 3 (moderate). Efficacy was assessed as the proportion of subjects who were considered a treatment success (defined as having an IGA score of 0 or 1 [clear or almost clear] and at least a 2-scale reduction from baseline). Treatment success was achieved in significantly more subjects using betamethasone dipropionate spray, 0.05%, than vehicle at both Day 15 and Day 29 across both studies. At Day 29 in Studies 1 and 2, betamethasone dipropionate spray, 0.05%, achieved treatment success of 42.7% and 34.5% compared to vehicle success rates of 11.7% and 13.6%, respectively (P<0.001).
