Exubera, an inhalable insulin being developed by Inhale Theraputics of San Carlos, California, and Pfizer, might have to wait a little while longer until it ‘breathes’ life into the diabetes market.
On July 18, the San Francisco Chronicle reported that Pfizer announced in an earnings statement that the U.S. Food and Drug Administration would probably want more safety data about possible side effects that have surfaced during clinical trials. According to the Chronicle article, last month Pfizer and Inhale revealed that patients who took a combination of injected and inhaled insulin produced more antibodies to the drug than patients who only injected insulin.
Exubera, a dry insulin powder that is inhaled into the lungs using a special device, was originally expected to submitted to the FDA for marketing approval by the end of this year. DIABETES HEALTH reported in its July issue that in clinical trials, one out of 1,000 patients that used Exubera developed lung damage.
Aradigm Corporation of Hayward, California, and Novo Nordisk are also developing an inhalable insulin called the AERx insulin delivery system.