Connetics wins FDA approval to market Olux for PsoriasisPALO ALTO, CA., Dec. 23, 2002 -- Connetics Corporation announced that the FDA has approved the company's supplemental New Drug Application (sNDA) to expand label claims for Olux (clobetasol propionate) Foam, 0.05%, 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, Connetics 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 percent 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."
Connetics designed the foam vehicle to be easier-to-apply, less messy and cosmetically more acceptable than currently marketed dermatological solutions, creams, ointments and gels. Foam liquefies when applied to the skin and is designed to deliver active drug to the disease site.
In a survey conducted by Connetics, 80% of patient responders said they preferred the foam to other topical vehicles. In another survey of dermatologists, 91% responded that they believed the foam would enhance patient compliance.
Source: Connetics Corporation www.connetics.com
Posted: December 2002