FDA Gives Its Approval For Inhaler

by Medindia Content Team on  January 28, 2006 at 6:53 PM General Health News   - G J E 4
FDA Gives Its Approval For Inhaler
An inhaler which is capable of regulating the blood sugar level has received the approval from the US Food and Drug Administration (FDA). This inhaler will be a source of relief to those people who are suffering from diabetes. The hand-held Exubera inhaler is a rapid-acting, dry powder human insulin that is inhaled through the mouth prior to eating.

It weighs four ounces and, when closed, is about the size of an eyeglass case. The unique inhaler produces in its chamber a cloud of insulin powder, which is designed to pass rapidly into the bloodstream to regulate the body's blood sugar levels. The FDA, which approved it on 27 January 2006, said the safety and efficacy of Exubera, the first new delivery system for insulin since it was developed some 80 years ago, have been studied in approximately 2,500 adult patients with type 1 and type 2 diabetes.

In clinical studies, peak insulin levels were achieved at 49 minutes (range 30 to 90 minutes) with Exubera inhaled insulin, compared to 105 minutes (range 60 to 240 minutes) for short-acting insulin. However smokers or those who quit smoking in the past six months should not use Exubera, the FDA said. It was also contraindicated for patients with asthma, bronchitis, or emphysema.

Edited (IANS)

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