FDA Approves Inhaled Insulin

Insulin

FDA APPROVES INHALED INSULIN
Authored by Stephanie McClain Riddle PharmD

The U.S. Food and Drug Administration approved an inhaled insulin product in June of this year. The new product is called AFREZZA and is manufactured by MannKind, based in California. The approval of the inhaled insulin product is viewed as a promising treatment option for patients with both type 1 and type 2 diabetes. This is not the first inhaled insulin. A similar product called EXUBERA, researched and developed by Pfizer and marketed in September 2006, was removed from market by Pfizer in October 2007 due to poor sales. Some product issues that contributed to the market failure of Exubera have been addressed in the formulation and delivery mechanism of AFREZZA, the new inhaled insulin product.

Afrezza falls in the category of a rapid-acting insulin, which means the inhaled dose of insulin is to be administered within 20 minutes of starting a meal. While many diabetics are hopeful of an insulin delivery system that avoids the use of needles completely, this product does not take the place of longer acting insulin administration in patients with type 1 diabetes.

The product carries a black box warning regarding the possible occurrence of acute bronchospasm in patients with asthma and chronic obstructive pulmonary disease. The most common adverse events seen in premarket clinical trials included episodes of hypoglycemia, cough, and throat pain or irritation. The evaluation of patients that are considered as possible candidates for this new insulin delivery device, requires clinicians to evaluate lung function and perform baseline spirometry testing.

The efficacy data results from premarket clinical studies showed Affrezza to reduce HbA1c levels to the predefined goal, but not as effectively as insulin aspart in patients with type 1 diabetes. The efficacy data determined by improved measures of HbA1c was also superior in type 2 diabetic patients.

It is unclear how this new insulin delivery system will be welcomed by practicing physicians. Many endocrinologists and primary care physicians are confident in current treatment strategies using injectable insulin. The additional required baseline testing may not make it conducive to the short visit times allotted in some primary office setting. Plus the drug will be expensive. Insurance payers may require additional information on a patient by patient basis to obtain their approval for payment.Watch movie online The Transporter Refueled (2015)

The FDA has requested additional data to be collected in 4 post-market studies. These studies will evaluate various parameters in pediatric diabetic patients, and specific types of trials in adults looking at pharmacokinetic and pharmacodynamic data. One mandated post market trial is designed to evaluate risks of pulmonary effects, the potential risk of pulmonary malignancy, and as assessment of cardiovascular risk in adult patients. Talk to your physician to see if you are a candidate for this new way of delivering insulin to both type 1 and type 2 diabetic patients.

References for this article are available upon request.
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