Sernivo Spray Hits Pharmacy Shelves

Posted By American Med Spa Association, Tuesday, June 7, 2016

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Dr. Reddy’s Laboratories’ US subsidiary, Promius Pharma, LLC, U.S. Sernivo™ Spray (betamethasone dipropionate) 0.05% was approved by the Food and Drug Administration (FDA) in February of 2016. The topical steroid spray is indicated for the treatment of mild-to-moderate plaque psoriasis in patients 18 years of age or older.
Promius conducted two 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 Sernivo Spray. In both trials, randomized subjects applied Sernivo Spray 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 Sernivo Spray than vehicle at both Day 15 and Day 29 across both studies. At Day 29 in Studies 1 and 2, Sernivo Spray achieved treatment success of 42.7% and 34.5% compared to vehicle success rates of 11.7% and 13.6%, respectively (p<0.001).
“As one of the researchers for Sernivo Spray, I’m excited to see this new treatment option added to our tool chest. With Sernivo Spray, I will now have a versatile option for patients that is easy to use in difficult to treat areas, like elbows and knees,” says Leon H. Kircik, M.D., clinical associate professor of dermatology at Indiana University School of Medicine, in a news release.
 
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