New inhalable insulin formulation approved

ExuberaInsulin human (rDNA origin)inhalation powderPFIZERNew inhalable insulin formulation approved

This novel formulation of human insulin is supplied as a powder in 1- and 3-mg dose blisters. The blisters are placed in an inhalation device for inhalation of the insulin dose as an alternative to injectable insulin. Insulin inhalation powder was approved on January 27, 2006, for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia.

Efficacy. The efficacy of insulin inhalation powder was assessed in approximately 2,500 adult patients with type 1 and type 2 diabetes. The primary efficacy parameter for most studies was glycemic control, as measured by the reduction from baseline in HbA1c. One study conducted in patients with type 1 diabetes compared insulin inhalation powder administered pre-meal 3 times daily (tid) and a single nighttime injection of human insulin extended zinc suspension with subcutaneous (SC) regular human insulin administered twice daily (bid) with a bid injection of human insulin isophane suspension. A second study conducted in patients with type 1 diabetes compared insulin inhalation powder with SC regular human insulin administered tid prior to meals. In each of these studies, the reduction in HbA1c was comparable for the 2 treatment groups. A randomized, open-label study of patients with type 2 diabetes not optimally controlled with diet and exercise compared tid insulin inhalation powder with an insulin-sensitizing agent. At 12 weeks, HbA1c levels in patients treated with insulin inhalation powder decreased 2.2% from a baseline of 9.5%. Another 12-week, open-label study was conducted in patients with type 2 diabetes who were currently receiving treatment, but were poorly controlled, with 2 oral agents (OA). These patients were randomized to either continue OA therapy alone, switch to pre-meal tid insulin inhalation powder monotherapy, or add pre-meal tid insulin inhalation powder to continued OA therapy. Insulin inhalation powder monotherapy and combination OA therapy were superior to OA therapy alone in reducing HbA1c levels from baseline. Similar studies were conducted to evaluate the use of insulin inhalation powder in combination with sulfonylurea or metformin in patients with type 2 diabetes compared with sulfonylurea and metformin or metformin and glibenclamide, respectively. In both of these studies, the regimens that included insulin inhalation powder were superior to the regimens that did not include insulin inhalation powder. The efficacy of insulin inhalation powder was also evaluated in comparison to SC insulin in patients with type 2 diabetes who were previously treated with SC insulin. At 24 weeks, reductions from baseline in HbA1c were similar between treatment groups

Dosing. In patients with type 1 diabetes, inhalable insulin should be used in regimens that include a longer-acting insulin. For patients with type 2 diabetes, inhalable insulin may be used as monotherapy or in combination with oral agents or longer-acting insulin. When used as mealtime insulin, the inhalation powder should be administered within 10 minutes before a meal. Initial pre-meal doses of inhalable insulin may be calculated using the following formula: [body weight (kg) X 0.05 mg/kg = pre-meal dose (mg)] rounded down to the nearest whole milligram number. A 1-mg blister of inhalable insulin is approximately equivalent to 3 IU of SC-injected regular human insulin. A 3-mg blister of inhalable inulin is approximately equivalent to 8 IU of SC-injected regular human insulin.

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