Halobtesol Propionate and Tazarotene Lotion Receives CRL for Plaque Psoriasis

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The fixed-dose combination therapy from Valeant Pharmaceuticals International is vying to become the first and only approved topical lotion for the condition.

FDA, CRL, complete response letter, valeant, DUOBRII, lotion

The US Food and Drug Administration (FDA) filed a Complete Response Letter (CRL) to Valeant Pharmaceuticals International's Ortho Dermatologics division in response to the company’s New Drug Application (NDA) for a potential plaque psoriasis therapy.

The CRL was filed in response to the November 2017 application for halobtesol propionate and tazarotene (DUOBRII), a topical lotion that would become the first and only lotion therapy approved for the treatment of plaque psoriasis, if eventually approved by the FDA. The investigative therapy is a fixed-combination lotion with complimentary mechanisms of action designed to treat adult patients.

Joseph C. Papa, chairman and chief executive officer of Valeant, said in a statement that the provided CRL did not specify any clinical efficacy or safety deficiencies — only questions regarding the pharmacokinetic data. The company is now responding swiftly to the issues presented.

“We are working to resolve this matter expeditiously and have already requested a meeting with the FDA,” Papa said. “We hope to bring forward this important new treatment option for those who suffer from plaque psoriasis as quickly as possible."

The data of a couple of phase 3 multi-center, double-blind, randomized studies were included in the company’s submitted NDA. The trials included 418 adult participants with plaque psoriasis.

The lotion reported statistical significant versus vehicle, with a treatment success rate of 45.33%. Primary endpoint of clear-to-almost-clear scoring based on Investigator Global Assessment (IGA) at Week 8 was met — as well as secondary endpoints of improvements by at least 2 IGA grade points at Weeks 2, 4, 6, and 12.

The most commonly reported adverse effects were contact dermatitis (7.4%) and application site pain (2.6%).

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