FDA Oks Foam Treatment for Adolescent Patients with Plaque Psoriasis

May 23rd 2019

Calcipotriene is a synthetic vitamin D analog that has a similar receptor binding affinity as natural vitamin D.

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

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Previously approved for adults,

the medication treats plaque psoriasis of the scalp and body.

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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.

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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.

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“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.

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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.

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Calcipotriene foam was approved by the FDA in 2010 for patients age 18 years and older.

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.

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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.

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References

  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.
  2. Sorilux. Prescribing Information. FDA website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022563s001lbl.pdf. Revised October 2010. Accessed May 23, 2019.

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