Inhaled insulin may be making a comeback. That's the hope at MannKind, a California-based biopharmaceutical company developing a rapid-acting inhaled insulin known as Afrezza (insulin human rDNA origin).
Inhaled insulin may be on the way back.
That's the hope at MannKind, a California-based biopharmaceutical company developing a rapid-acting inhaled insulin called Afrezza (insulin human rDNA origin). The company has a New Drug Application under review by FDA and hopes to receive marketing approval toward the end of 2010. The only inhaled insulin to be approved for the U.S. market was withdrawn in 2007 for lack of interest.
Afrezza is an ultra-rapid mealtime insulin delivered with a high-resistance inhalation device about the size of a whistle. A single-dose cartridge is loaded into the inhaler and taken at the beginning of a meal. Peak serum levels are reached in 12 to 14 minutes, Dr. Richardson noted, which mimics the release of endogenous insulin in healthy individuals. About 80% of Afrezza is metabolized within 3 hours of administration compared to 30% of injected rapid-acting insulin. The rapid onset and disappearance of active drug are responsible for improved clinical response.
"Standard mealtime insulin therapies are effective in managing blood sugars but are known to cause weight gain and severely low blood-sugar levels," said Philip Raskin, chair of biomedical research, University of Texas Southwestern Medical School, Dallas, speaking at the American Association of Clinical Endocrinologists annual meeting earlier this year. "Our study shows that treatment regimens incorporating Afrezza offer glycemic control comparable to convention regimens with the added benefits of weight loss and less incidence of hypoglycemia."