U.S. Government Carefully Evaluating Inhaled Insulin Product For Diabetics. Companies Are Competing to Deliver Next Generation Insulin Doses.
The U.S. Food and Drug Administration (FDA) is considering approval of Exubera, an inhaled form of insulin created to help millions of diabetics who currently must rely on injections to regulate their blood sugar. The inhaled insulin is being developed by Pfizer [NYSE: PFE], Sanofi-Aventis [NYSE: SNY], and Nektar Therapeutics [NASDAQ: NKTR]. The FDAâ€™s Endicrinologic and Metabolic Drugs Advisory Committee are deciding whether to recommend the drug to government regulators for review and approval. During Exuberaâ€™s trials, researchers found that inhaled insulin was overall as effective as injections, but that some patients did complain of coughing and a small decrease in breathing capacity.
The insulin and injector market is a $3 billion dollar industry. Currently, the three most viable methods for insulin delivery into the upper airways include the nose, lungs, and mouth. Insulin inhaled through the nose and mouth have proven to be difficult due to the medicine having to pass through various parts of the body thus affecting dosage effectiveness. But Insulin inhaled through the lungs brings it directly into the lungs. Insulin absorption into the bloodstream occurs through the thin alveolar wall found in the lung, and this appears to be the most promising approach for insulin delivery to date.
A number of companies are competing for insulin delivery through the lungs. Inhale Therapeutics Systems (now Nektar Therapeutics), which presented their results and findings at an ADA meeting, has created a particle containing 20% insulin in micron size, which is ideal for deep lung delivery. The other 80% of the particle was not disclosed by ITS, but it is most likely albumin, a common protein in the body that does not activate the immune system. The technology created by the ITS addresses the most vital element in drug delivery to a massive surface areaâ€”creating a particle small enough to travel down the throat yet not large enough to breathed out of the lungs into the air.