Bausch Health Announces U.S. Launch of DUOBRII™ (halobetasol propionate and tazarotene) Lotion 0.01%/0.045% for Plaque Psoriasis in Adults
LAVAL, Quebec, June 25, 2019 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that DUOBRII™ (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, will be available commercially to health care professionals starting this week. Approved by the U.S. Food and Drug Administration on April 25, 2019, DUOBRII is the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation.
"The launch of DUOBRII marks the fifth innovative therapy that Ortho Dermatologics has brought forward within the last 30 months," said Bill Humphries, president, Ortho Dermatologics. "The DUOBRII formulation brings together two well-known ingredients in a unique lotion vehicle with low concentrations of halobetasol propionate and tazarotene, into a single, first-of-its-kind topical treatment. We are proud to provide plaque psoriasis patients this important new option, which offers strong efficacy and an extended duration of use in an advanced once daily lotion that can be dosed to clearance."
When used separately to treat plaque psoriasis, the duration of use of halobetasol propionate is limited by FDA labeling constraints to two to four weeks duration and the use of tazarotene can be limited due to tolerability concerns. By combining halobetasol propionate and tazarotene in a patented once-daily moisturizing lotion, the DUOBRII formulation ensures uniform distribution, allowing for simultaneous contact with the skin surface.1 In a year-long safety study, patients used DUOBRII for up to 24 weeks of continuous use and up to 52 weeks of as-needed use.2 Unlike other topical products that either contain steroids or are steroids on their own, DUOBRII is not restricted to eight weeks or less of use. The approved labeling for DUOBRII does not include a duration limitation; it can be dosed to clearance as long as local skin reactions do not occur, and treatment should be discontinued once clearance is achieved.
"Combination therapy is an important tool in the treatment of plaque psoriasis and, with the launch of DUOBRII, I am excited to offer patients a new option that provides the known benefits of a potent topical corticosteroid and a topical retinoid, with synergistic efficacy," said Lawrence J. Green, M.D., associate clinical professor of Dermatology, George Washington University School of Medicine, Washington, D.C. "Due to its tolerability profile, I believe many psoriasis patients will be able to benefit from the longer duration of use possible with DUOBRII."
DUOBRII Lotion is priced at $825 for a supply of a 100-gram tube, which is more than 50 percent lower than other branded topical combination products.* Additionally, through the company's access program, most eligible, commercially insured patients will have a co-pay as little as $25.
DUOBRII Comprehensive Clinical Data
A Phase 2 study demonstrated DUOBRII Lotion was consistently more effective than its individual agents and vehicle in achieving treatment success (defined as at least a two-grade improvement from baseline in an Investigator Global Assessment (IGA) score, and 'clear' or 'almost clear' skin) and reducing psoriasis signs of erythema, plaque elevation, and scaling at the target lesion.3 In addition, a post-hoc analysis of the data, in which the vehicle effect was removed, showed that the efficacy of DUOBRII was superior to the aggregated results of the individual agents, supporting the synergy of the two ingredients when combined in one lotion formulation.
The safety and efficacy of the once daily use of DUOBRII for the treatment of plaque psoriasis were assessed in two Phase 3 prospective, multi-center, randomized, double-blind clinical trials in subjects 18 years and older with moderate to severe plaque psoriasis.1
Studies 1 and 2, which enrolled a total of 418 patients, showed DUOBRII was consistently more effective than vehicle in achieving treatment success (primary endpoint at eight weeks), demonstrating statistically significant superiority by week four (in Study 1) and week two (in Study 2). At week eight, 36 percent (Study 1) and 45 percent (Study 2) had achieved the primary efficacy outcome, compared to seven percent and 13 percent on vehicle (both p<0.001). The majority of responders maintained treatment success over the four-week post treatment period. The most common adverse events in clinical trials were contact dermatitis (seven percent), application site pain (three percent), folliculitis (two percent), skin atrophy (two percent), and excoriation (two percent).1
A third Phase 3 multicenter, open-label study assessed the long term safety of DUOBRII over the course of a year in subjects with plaque psoriasis. Patients used DUOBRII once daily for eight weeks and were re-evaluated every four weeks after for a year. Continuous treatment was allowed up to 24 weeks and as needed for up to 52 weeks. The most common treatment-related adverse events (≥2%) were application site reactions such as itching, pain, irritation and inflamed hair follicles (folliculitis).2
Important Safety Information
What is DUOBRII™ Lotion?
Important Safety Information
What is the most important Information I should know about DUOBRII Lotion?
Before you use DUOBRII Lotion, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What should I avoid during treatment with DUOBRII?
DUOBRII may cause side effects, including:
The most common side effects of DUOBRII Lotion include: redness, itching, swelling, burning, stinging, application site pain, inflamed hair follicles (folliculitis), thinning of the skin (atrophy), peeling and rash.
To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch
Please click here for full Prescribing Information.
Visit https://www.duobrii.com/ to learn more.
About Ortho Dermatologics
About Bausch Health
*DUOBRII's per gram WAC cost is $8.25, which is 52.9% lower than competitor products. WAC Pricing Source: MediSpan PriceRx as of April 23, 2019.
DUOBRII is a trademark of Ortho Dermatologics' affiliated entities.
View original content to download multimedia:http://www.prnewswire.com/news-releases/bausch-health-announces-us-launch-of-duobrii-halobetasol-propionate-and-tazarotene-lotion-0-010-045-for-plaque-psoriasis-in-adults-300873920.html
SOURCE Bausch Health Companies Inc.
Company Codes: NYSE:BHC, Toronto:BHC