Connetics Begins Trial With Primolux for Atopic Dermatitis, Psoriasis
Connetics has commenced the Phase III clinical program for Primolux (formerly referred to as OLUX-EF), a super high-potency topical steroid, formulated with 0.05 percent clobetasol propionate in the company's proprietary VersaFoam-EF emulsion foam delivery vehicle.
The clinical program will consist of two Phase III trials focusing on atopic dermatitis and psoriasis. Subject to successful Phase III trial outcomes, Connetics intends to submit a new drug application to the FDA by the end of 2005.
Primolux represents Connetics' second product entry into the super high-potency topical steroid market. The annual U.S. market opportunity for super high-potency topical steroids in all specialties is currently estimated to exceed $545 million.
Primolux will be delivered in the VersaFoam-EF emulsion formulation, a completely different delivery vehicle than OLUX, which utilizes the hydro-ethanolic VersaFoam formulation. The VersaFoam-EF delivery vehicle will allow Primolux to compete in a new segment of the super high-potency topical steroid market.