FDA Approves Allergan's Tazorac

Allergan has been granted marketing clearance from the US Food and DrugAdministration for once-daily Tazorac (tazarotene topical gel), for the treatment of stable plaque psoriasis on up to 20% of body surface area (0.05% and 0.1% strength) and mild-to-moderately severe facial acne (0.1% strength). This is the first of a new generation of topical, receptor-selective retinoids to be marketed for both these indications, says the company. The approval also represents Allergan's first new molecule to reach the US marketplace.

Tazorac is thought to work by normalizing epidermal differentiation, reducing hyperproliferation and lowering the influx of inflammatory cells into the skin, says the company.

In clinical trials, success rates of up to 70% were recorded in patients with stable plaque psoriasis, with therapeutic effects sustained for up to 12 weeks following treatment. An efficacy of up to 70% was also noted in acne clinical trials. Side effects were transient, with mild-to-moderate manifestations of manageable local irritation, including itching, burning and erythema. The company commented that the effects of Tazorac are greatly enhanced when it is used in combination with mid-to-high potency steroids, and that local side effects are much reduced compared to the use of the drug as a monotherapy (Marketletter May 5).