In wake of news that its inhaled insulin product Exubera has been linked to lung cancer, Pfizer Inc. has announced that it will cease manufacturing the drug and update labels on the remaining product to carry a cancer warning.
The company revealed that in a study of 4,740 patients taking Exubera, six developed lung cancer (1 out of every 780). In comparison, one out of 4,292 patients in the study who were not taking Exubera developed lung cancer.
Pfizer introduced Exubera in 2006 as the first inhaled insulin product on the market. By 2007, however, the company announced that it would cease marketing the product because of low demand. An estimated 4,000 people with diabetes worldwide are taking the drug.
Before receiving FDA approval to market Exubera, the drug’s apparent effects on lung function had been noted in studies – a concern that delayed approval for several years.
Inhaled insulin has been a kind of Holy Grail for pharmaceutical manufacturers since it avoids the pain and inconvenience of needle injections. When Pfizer ceased marketing Exubera last year, Novo Nordisk and Eli Lilly soon dropped their inhaled insulin development programs.
Valencia, Calif.-based MannKind Corp. has said it will continue work on its Technosphere inhaled insulin product.
Oramed Begins Studies on Oral Insulin Capsule
Israeli company Oramed Pharmaceuticals, Inc., a developer of oral delivery systems, has commenced Phase 2A studies on its oral insulin capsule at the Hadassah Medical Center in Jerusalem. The trial will focus on assessing the safety and efficacy of the capsule on 10 type 2 diabetes patients. This study is a continuation of the recently successfully completed Phase 1 studies in Israel.