SPL receives FDA Special Protocol Assessment for BV Phase 3
Melbourne, Australia; Starpharma (ASX: SPL; OTCQX SPHRY) today announced that it has received final written agreement from the FDA on the design of its Phase 3 clinical studies of VivaGel® for the treatment of bacterial vaginosis (BV) under the FDA’s Special Protocol Assessment (SPA) scheme.
The SPA is a binding declaration from the FDA that the Phase 3 clinical study design, endpoints, statistical analyses, and other aspects of the planned studies are acceptable to support regulatory approval of the product.
“Receiving this SPA agreement gives Starpharma great confidence in our Phase 3 program, and allows us to proceed through this final development stage with a high level of clarity about the approval pathway for VivaGel® for treatment of BV,” said Dr Jackie Fairley, Chief Executive Officer of Starpharma.