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FDA Approves Inhaled Insulin

Posted on January 1, 2018 | No Comments on FDA Approves Inhaled Insulin

Exubera, manufactured by Pfizer, Inc., became the first inhaled insulin to get approval from the United States Food and Drug Administration (US FDA). The FDA approval came late January this year, giving the makers of Exubera license to market the product for the treatment of adults with type I and type 2 diabetes. It has been found in clinical trials that Exubera is as effective as short-acting insulin injections, and that it significantly improves blood sugar control when added to diabetes pills.

Exubera is a rapid-acting, dry powder human insulin that is inhaled through the mouth before a meal. The device delivers short-acting insulin via an inhaler and offers adults with type I or type 2 diabetes an alternative to insulin injections. However, the device was not approved for use by children younger than 18years old. It is also not recommended to be used by smokers or those who have quit smoking within the previous six months, as well as for people with asthma, bronchitis or emphysema. People with colds or flu should still be able to take the drug, although it may cause coughing.

Although it works similar to an inhaler, the device is not the same size as an asthma inhaler, rather it’s the size of a standard flashlight when folded up, and is about the size of an eyeglass case when closed. When using it, a retractable inhaler tube comes out from the body of the device, and when extended, it reaches from the chest to the mouth. To start using the device, a blister pack of insulin must be inserted.

The FDA approval requires the manufacturers to distribute medication guides that contain FDA-approved information, along with Exubera. FDA further recommends that patients get tested for good lung function before starting treatment with Exubera, and that the tests should be repeated every six to twelve months while treatment continues. The approval also calls for further long-term studies to confirm the safety of the device. Manufacturers expect the product to be on pharmacy shelves by middle of this year in the US.

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