Manhattan Pharmaceuticals, Inc. announced that the company has reached an agreement with the US 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, multi-centre 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.
Manhattan Pharmaceuticals, Inc. is a specialty healthcare product company focused on the development and commercialization of innovative treatments for underserved patient populations.