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