Healthcare company Bausch Health Companies Inc (NYSE/TSX:BHC) and its Ortho Dermatologics dermatology business reported on Thursday the receipt of approval from the US Food and Drug Administration (FDA) for the New Drug Application for DUOBRII Lotion, 0.01%/0.045% for the topical treatment of plaque psoriasis in adults.
Plaque psoriasis is 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.
According to Bausch Health, DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation. A Phase 2 study demonstrated that the product was consistently more effective than its individual agents and vehicle in achieving treatment success.
In the company's year-long safety study, patients applied DUOBRII Lotion for up to 24 weeks of continuous use and up to 52 weeks of as-needed use.
Expected to be available in June 2019, DUOBRII Lotion is priced at USD825 for a supply of a 100-gram tube, which is more than 50% lower than other branded topical combination products. The company's access programme provides commercially insured patients with a co-pay between USD25 and USD40.
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