The FDA has approved betamethasone dipropionate spray, 0.05%, as a treatment for mild to moderate plaque psoriasis in patients aged 18 years and older.
The FDA has approved betamethasone dipropionate (Sernivo) spray, 0.05%, as a treatment for mild to moderate plaque psoriasis in patients aged 18 years and older.
The spray, created by Promius Pharma, a subsidiary of Dr. Reddy’s, will be launched in the coming quarter.
“The FDA approval of Sernivo Spray is a significant milestone for Promius, as it validates our committed efforts and resources to developing differentiated dermatology products from concept to commercial launch,” said G V Prasad, co-chairman and CEO of Dr. Reddy’s Laboratories, in a press release. “We are delighted to receive a first round FDA approval of Sernivo Spray as we look to expand our portfolio of medical dermatology products available in the US market.”
The FDA approval is based on data from 2 clinical trials involving patients who were randomly assigned to receive Sernivo Spray or a vehicle spray to affected areas twice daily for 28 days. Patients who used the intervention treatment saw significantly more success in treatment compared with the placebo group.
In the clinical trials, the most common adverse effects associated with either Sernivo Spray or placebo were application site reactions, including burning or stinging, pain, and atrophy.
Patients who use Sernivo Spray should not use it on their face, scalp, axilla, or groin.
In addition, health care providers should inform patients not to use the treatment for more than 4 weeks.