Manhattan Pharmaceuticals, Inc. Reaches Agreement With the FDA on a Special Protocol Assessment for the Phase 3 Clinical Study of AST-726
NEW YORK, July 21, 2011 (GLOBE NEWSWIRE) -- Manhattan Pharmaceuticals, Inc. (OTCBB:MHAND) announced that the Company has reached an agreement with the U.S. Food and Drug Administration (FDA) on a special protocol assessment (SPA) for the design of a Phase 3 clinical trial of AST-726 in patients with a confirmed medical history of vitamin B12 deficiency. Manhattan has designed an open label, multicenter study for investigating the maintenance of trough serum cobalamin levels after monthly administration of AST-726, with a goal of enrolling approximately 75 subjects and a goal of having 53 evaluable subjects complete the study.
An SPA is a written agreement with the FDA that the study design and planned analysis of the sponsor's Phase 3 clinical trial adequately addresses the objectives necessary to support a regulatory submission.
AST-726 is an intranasal spray formulated as an isotonic aqueous solution of hydroxocobalamin acetate with preservatives.
About Manhattan Pharmaceuticals, Inc.
Manhattan Pharmaceuticals, Inc. is a specialty healthcare product company focused on the development and commercialization of innovative treatments for underserved patient populations. The company is currently focused on two programs: AST-726, a nasally delivered vitamin B12 remediation treatment, and AST-915, an orally delivered product candidate for the treatment of essential tremor.