AFRESA Inhalation Powder and AFRESA Inhaler NDA under FDA review

AFRESA^® (insulin human [rDNA origin]) Inhalation Powder is a well-tolerated, ultra rapid acting insulin able to more closely replicate normal glucose suppression than currently available insulins, according to data presented at the 45^th Annual Meeting of the European Association for the Study of Diabetes. Results from the open-label, single-dose, three-way crossover study showed that endogenous glucose production (EGP) was suppressed earlier following AFRESA administration compared with subcutaneous insulin lispro and inhaled Exubera in adult patients with type 2 diabetes. The inability to effectively suppress endogenous glucose production significantly increases the risk of fasting hyperglycemia in individuals with type 2 diabetes.

“Many people do not appreciate that most of the excess postprandial glucose increase in individuals with diabetes is due to inadequate suppression of endogenous glucose production by the liver,” said Jay S. Skyler, M.D., MACP, Professor, Division of Endocrinology, Diabetes, & Metabolism, Associate Director, Diabetes Research Institute, University of Miami Miller School of Medicine. “This study demonstrates that more rapid insulin availability better suppresses EGP.”

AFRESA is a novel, ultra rapid acting mealtime insulin therapy with an action profile that mimics meal-related early insulin release. Based on an extensive phase 2/3 clinical program, a New Drug Application (NDA) is currently under review by the U.S. Food and Drug Administration (FDA) requesting approval to market AFRESA Inhalation Powder and the AFRESA Inhaler for use in adult patients with type 1 and type 2 diabetes mellitus for the treatment of hyperglycemia. AFRESA is conveniently administered by oral inhalation.