FDA OKs Topical Drug Combo (Enstilar) for Plaque Psoriasis

Megan Brooks


October 20, 2015

The US Food and Drug Administration (FDA) has approved a foam containing calcipotriene and betamethasone dipropionate (Enstilar, Leo Pharma Inc) for topical treatment of plaque psoriasis in adults 18 years of age and older, according to a company news release.

Enstilar is an alcohol-free foam formulation of the two drugs in a pressurized spray that permits application across large areas of plaque psoriasis. It is applied once daily to affected areas for up to 4 weeks. Patients should stop using it when control is achieved and should be instructed not to use more than 60 g every 4 days, the company notes in its release.

"The approval of Enstilar may offer the appropriate plaque psoriasis patients a new treatment option in an elegant vehicle that provides rapid relief from symptoms," Barbara J. Osborne, president and chief executive officer of LEO Pharma Inc, said in the release.

In a phase 3 clinical trial, more than half of patients treated with Enstilar were "clear" or "almost clear" by week 4, as assessed by the Investigator Global Assessment score of disease severity, the company said. In addition, more than half of patients who used the product achieved 75% improvement in Psoriasis Area and Severity Index score from baseline.

Adverse reactions were reported in fewer than 1% of patients treated with Enstilar and included application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis, the company said. "If hypercalcemia or hypercalciuria develop, patients should discontinue treatment until parameters of calcium metabolism have normalized," they advise.

"For the vast majority of plaque psoriasis patients using topical therapies as a first-line treatment option, having a therapy that can safely and effectively treat their symptoms is key," Craig Leonardi, MD, clinical professor of dermatology at Saint Louis University School of Medicine in Missouri, and lead investigator of the clinical trial, said in the news release.

"The approval of Enstilar provides patients living with plaque psoriasis a new topical treatment option that was shown to be more effective than the ointment fixed combination and the individual components used alone," he added.


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