Connetics Corporation announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) to expand label claims for OLUX (clobetasol propionate) Foam, 0.05 per cent to include the short-term topical treatment of mild to moderate plaque-type psoriasis of non-scalp regions excluding the face and intertriginous areas.
OLUX was previously approved for the short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp including psoriasis. In late October, the Company announced receipt of an Approvable Letter from the FDA regarding this sNDA.
"The approval of our sNDA for OLUX allows us to address a substantially larger market as approximately 80 per cent of all prescriptions for psoriasis are for areas of the body other than the scalp," said Thomas G. Wiggans, Connetics President and Chief Executive Officer. "Our sales force will now be able to promote a therapeutic option for dermatologists to treat the many patients with psoriasis affecting non-scalp regions. We believe this approval will offer an important advantage as patients can receive one prescription to treat multiple areas of the body as opposed to receiving multiple prescriptions, which is often the case."