FDA approves Inhaled Insulin

FDA approves Inhaled Insulin
The F.D.A. recently approved the drug, Exubera. Exubera is inhaled insulin for use of adult diabetics only. The drug is expected to be released sometime this year. Exubera is produced by Pfizer.

Exubera is delivered by inhaling insulin as opposed to injection from traditional insulin. However, Exubera will not replace all injected insulin but used as a supplement to a diabetics normal regime. This drug is administered by a flashlight sized device and would be used to reduce or eliminate the need for before meal insulin shots. However, long acting insulin will still be required by the patient.

According to the National Diabetes Information Clearinghouse an estimated 20.8 million people are affected with diabetes with another 6.2 million who have been undiagnosed.
Of the 20.8 million diabetes 57% are on oral medications, 16% on insulin, 12% on a combination of both and 15% don’t use any medications.

The F.D.A. panel originally voted 7-2 in favor of Exubera with concerns about long term effects for patients with lung diseases along with diabetes. Their main concern was with people who smoked, exposed to smoke or had a lung disease. These conditions might prevent or inhibit the inhaled insulin properties. Pfizer’s safety and efficacy trials found other side effects including hypoglycemia (low blood sugar), respiratory tract infections, cough and an inflammation called pharyngitis. Pharyngitis is an inflammation of the pharynx that frequently results in a sore throat. It may be caused by a variety of microorganisms. With the release of this drug 5000 patients will be carefully monitored to prevent further complications.

Exubera is to replace the short acting insulin normally used at meals and not the long acting insulin. This drug will be used as a replacement to Humalog, Novalog, Humalin,Novalin, and Verosulin. Patients will still continue their long acting insulin and use Exubera and be closely monitored.

The release of Exubera has been long awaited since recently diagnosed Type 1 or Type 2 diabetics are afraid of needles. Many long time diabetics are also tired of injections. Restrictions on the drug will be for smoker and diabetics with other lung ailments such as asthma and chronic obtrusive pulmonary disease should not use this drug.

This drug is only a tip of the iceberg as drug company’s look for better delivery systems and cures in the fight against diabetes. There will be more innovate and interesting drugs as more research is done on the root cause of diabetes.

You Should Also Read:
Drug Development
Exubera Official Site

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