Inhaled Insulin Could be Restricted

Pfizer Inc.’s inhaled insulin, delayed three years due to safety tests, is set to face marketing hurdles which include regulatory limits on use when it is eventually approved for sale. So say market analysts about Pfizer’s Exubera, the forerunning diabetes treatment that is absorbed into the blood through the lungs.
Exubera is being considered by a U.S. Food and Drug Administration advisory panel today.
The panel may recommend that the agency okays the treatment, analysts said, only after the company responds to questions about how safe the drug is for diabetics who have with lung problems.
Pfizer assumes patients want an alternative to daily injections, yet many are not necessarily ready to do so. The primary concern would be the safety of the new drug and testing results for side effects.
Eli Lilly first introduced commercial insulin in 1922. Diabetics have to monitor blood sugar levels, ensuring they do not soar by taking insulin, moderate their diet and exercise.
Pfizer were expecting to introduce inhaled insulin in 2002. The company however delayed seeking approval after discovery of a 1% reduction of lung function in a test. Pfizer since has conducted studies that found that insulin causes a 1% decrease in respiratory function, whether injected or inhaled, said Hank McKinnell, the company’s chief executive.
“I still have a nagging concern about potential long-term impact,” said Howard Wolpert, a doctor at the Joslin Diabetes Center in Bosto, last month. “With insulin, one needs a fairly precise dose. Frankly, I am a little bit skeptical about whether they’ll get that with an inhaler.”

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