FDA Approves Duobrii (halobetasol propionate and tazarotene) Lotion 0.01%/0.045% for Plaque Psoriasis In Adults

Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for Duobrii (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, indicated for the topical treatment of plaque psoriasis in adults.1 Duobrii is the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation. In a year-long safety study, patients used Duobrii Lotion for up to 24 weeks of continuous use and up to 52 weeks of as-needed use.2 Duobrii is expected to be available in June 2019.

"With today's approval of Duobrii, patients suffering from plaque psoriasis now have an innovative topical treatment option that uniquely combines two well-known ingredients, halobetasol propionate and tazarotene, with established safety profiles, into a single lotion featuring dual mechanisms of action," said Bill Humphries, president, Ortho Dermatologics. "Since psoriasis is a chronic skin disease, patients require continuous treatment in order to achieve optimal control of their symptoms. Now, with Duobrii, health care professionals and their patients have a new topical treatment option that can help them achieve those long-term goals. As a result, we believe that Duobrii has the potential to delay some patients from switching to more expensive biologic treatments, which could potentially result in health care savings."

Continued Mr. Humphries, "We remain committed to bringing forward new medicines, like Duobrii, to add to our portfolio of topicals and biologics to meet the varying treatment needs of patients with psoriasis."

When used separately to treat plaque psoriasis, the duration of use of halobetasol propionate is limited by FDA labeling constraints and the use of tazarotene can be limited due to tolerability concerns. By combining halobetasol propionate and tazarotene in an advanced, patented once-daily moisturizing lotion, the Duobrii formulation ensures uniform distribution, allowing for simultaneous contact with the skin surface.1

In the United States, approximately 7.5 million people live with psoriasis, with 80 percent having plaque psoriasis.3 Plaque psoriasis is the most common type of psoriasis, a chronic, non-contagious skin disease that alters the life cycle of skin cells, causing them to build up rapidly on the surface of the skin.4,5

"Duobrii provides the known benefits of a potent topical corticosteroid and a topical retinoid with synergistic efficacy. Combination therapy is the mainstay of topical treatment for plaque psoriasis, making Duobrii an important new option," said Linda Stein Gold, M.D., director, Dermatology Clinical Research, Henry Ford Health System. "Although effective, topical retinoids have had limited use as monotherapy due to tolerability concerns. Duobrii provides improved local tolerability, allowing patients to benefit from an extended duration of use."

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 between $25 and $40.

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.6 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 include redness, itching, swelling, burning, stinging, application site pain, inflamed hair follicles (folliculitis), thinning of the skin (atrophy), peeling and rash.1

A third Phase 3 multicenter, open-label study assessed the long term safety of Duobrii over a year in subjects with plaque psoriasis. Patients were given Duobrii once daily for eight weeks and 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. Treatment related adverse events > two percent were application site reactions such as itching, pain, irritation and inflamed hair follicles (folliculitis).

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