Tazarotene acne treatment lotion is one step closer to market

14-Aug-2019 - Last updated on 14-Aug-2019 at 15:18 GMT

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Related tags New drug application Acne

Last week, Bausch Health Companies announced that a New Drug Application for tazarotene acne treatment lotion filed by the company’s skin health business, Ortho Dermatologics, was accepted by the US FDA. If approved, the lotion would be the first of its kind.

“If approved, IDP-123 will offer physicians and their patients a lower concentration of tazarotene in a lotion formulation, helping to further expand upon our growing portfolio of acne treatments,” explains, Ortho Dermatologics president Bill Humphries, in a press release about the new drug application.

The multinational Quebec, Canada – based Bausch Health Companies makes over-the-counter (OTC), pharma, and medical products, and specializes in eye health, gastroenterology, neurology, aesthetics, and dermatology.

While many of the company’s dermatology products are only available with a prescription or for use in a professional setting (Retin-A cream and gel, for instance), some like Caladryl, Cortaid, ESOTERICA moisturizers, Purpose Cleansing Wash, and the Shower-to-Shower products do not.

Treatment pending approval

The New Drug Application (NDA) that Ortho Dermatologics filed with the FDA was for its IDP-123 (tazarotene 0.045%) Lotion. As part of the application, the company included data from two studies. In both phase 3 randomized, placebo-controlled, double-blind clinical trials that included more than 1,500 people.

According to the company’s press release, “The primary efficacy endpoints included the absolute change in the mean noninflammatory and inflammatory lesion counts, the percentage of subjects who had a least a two-grade improvement from baseline to week 12 in the Evaluator Global Severity Score (EGSS) and who had "clear" or "almost clear" skin. In both Phase 3 studies, all primary efficacy endpoints were met with statistical significance (p<.001). IDP-123 was also shown to be well-tolerated in the clinical study population. The most common adverse events were application site pain, application site dryness and application site exfoliation.”

The FDA will complete its review by or before the end of 2019.

Corporate financial notes

Last week’s Q2 financial results show Ortho Dermalogics brought in 6% of Bausch Health Companies’ revenue for the quarter ($2.152bn), a figure that accounts for $122m. That’s down 13% from the same quarter last year when the skin health business brought in $141m.

Commenting on the quarterly report, Joseph C. Papa, chairman and CEO of Bausch, says, “Delivering a second consecutive quarter of reported and organic revenue growth, our second quarter 2019 results demonstrate that Bausch Health is clearly pivoting to growth.”

“Looking to the second half of 2019,” continues Papa, “we expect a number of catalysts to drive growth across our core business segments as we continue to reduce debt, increase R&D and further grow our newly launched products.”

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Deanna Utroske, CosmeticsDesign.com Editor, covers beauty business news in the Americas region and publishes the weekly Indie Beauty Profile column, showcasing the inspiring work of entrepreneurs and innovative brands.