Treatment for Plaque Psoriasis in Adolescent Patients Granted FDA Approval
Calcipotriene foam was approved by the FDA in 2010 for patients age 18 years and older.
Officials with the FDA have approved Mayne Pharma’s calcipotriene (Sorilux) foam, 0.005% for adolescent patients, according to the company.1
Previously approved for adults,2 the medication treats plaque psoriasis of the scalp and body.1
Calcipotriene is a synthetic vitamin D analog that has a similar receptor binding affinity as natural vitamin D. The exact mechanism of action contributing to the clinical efficacy is unknown.1
Psoriasis is a chronic disease of the immune system that affects approximately 7.5 million people each year
in the United States. Plaque psoriasis is the most common form of condition, affecting about 80% of patients with psoriasis.
“Topical products are the mainstay of treatment for plaque psoriasis patients and the foam delivery platform has a well-established reputation with dermatologists due to ease of application and lack of greasiness and stickiness, especially in hair-bearing areas and under clothing," said Mayne Pharma's CEO, Mr Scott Richards
, in a prepared statement.
Mayne recently launched a halobetasol propionate foam (Lexette), a potent topical corticosteroid also used to treat plaque psoriasis in adult patients. The calcipotriene foam is indicated for patients aged 12 years and older.1
Calcipotriene foam was approved by the FDA in 2010 for patients age 18 years and older.2 The earlier approval was based on evidence from a pair of 8-week placebo controlled clinical trials in patients with mild to moderate plaque psoriasis of the body and an 8-week placebo controlled clinical trial in patients with moderate plaque psoriasis of the scalp.1
Additional data was obtained in a follow-on open label study in patients aged 12 to 17 years of age with psoriasis, according to Mayne.1
- FDA Approves SORILUX(R) for Adolescent Plaque Psoriasis [news release]. Adelaide, Australia; May 22, 2019: Mayne Pharma. https://www.prnewswire.com/news-releases/fda-approves-soriluxr-for-adolescent-plaque-psoriasis-300854930.html. Accessed May 23, 2019.
- Sorilux. Prescribing Information. FDA website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022563s001lbl.pdf. Revised October 2010. Accessed May 23, 2019.