FDA Grants Approval for Treatment for Plaque Psoriasis in Adolescent Patients

OTC Guide, June 2019, Volume 23, Issue 1

FDA officials have approved Mayne Pharma’s calcipotriene (Sorilux) foam, 0.005% for adolescent patients, according to the company.1

FDA officials 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 body and scap.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 about 7.5 million people each year in the United States. Plaque psoriasis is the most common form of the condition, affecting about 80% of patients with psoriasis.1

“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,” Mayne Pharma’s Chief Executive Officer Scott Richards said in a statement.1

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 12 and older.1

The FDA approved Calcipotriene foam in 2010 for adults.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 were obtained in a follow-on open label study in patients aged 12 to 17 with psoriasis, according to Mayne Pharma.1

References

  • FDA approves SORILUX(R) for adolescent plaque psoriasis [news release]. Adelaide, Australia; May 22, 2019: Mayne Pharma. www.prnewswire.com/news-releases/fda-approves-soriluxr-for-adolescent-plaque-psoriasis-300854930.html. Accessed May 23, 2019.
  • Sorilux [prescribing Information.] Stiefel Laboratories, Inc. Research Park, NC: 2012. accessdata.fda.gov/drugsatfda_docs/label/2012/022563s002lbl.pdf. Accessed May 23, 2019.