FDA grants tentative approval for Bryhali Lotion for the topical treatment of Psoriasis.-Ortho Dermatolpgics

Bausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, announced that the FDA has provided tentative approval of the New Drug Application for Bryhali (halobetasol propionate) Lotion, 0.01%, for the topical treatment of plaque psoriasis in adult patients.

Bryhali Lotion is a new potent to superpotent corticosteroid that contains 0.01 percent halobetasol propionate in a novel vehicle lotion. Its safety has been established in clinical trials with dosing for up to eight weeks with no increase in epidermal atrophy. The final FDA approval for Bryhali Lotion is pending the expiration of exclusivity for a related product, which is expected in early November 2018. The company plans to launch Bryhali Lotion shortly thereafter, as scheduled, in November 2018.

Comment: Topical steroids are the most frequently used treatment for psoriasis, but long-term use has been limited due to risks of adverse events such as epidermal atrophy. Other local adverse reactions from topical corticosteroids may include striae, telangiectasias, hypopigmentation and contact dermatitis, and some local adverse reactions may be irreversible. In clinical trials,Bryhali Lotion was applied once daily for eight weeks and shown to be generally well-tolerated with no increase in epidermal atrophy.