For everybody who hates needles, MannKind Corporation (MNKD) has initiated patient enrollment in its phase 3 safety trial of inhaled insulin in the United States. The study will evaluate the pulmonary safety of the firm's Technosphere Insulin product in patients with type 1 and type 2 diabetes. An initial phase 3 efficacy study was announced in Europe in late 2004.
MannKind recently presented data at the American Diabetes Association from a completed phase 2b study showing significant reductions in HbA1c levels over a three-month period with no increase in the risk of hypoglycemia. The Company is in the process of scaling up its manufacturing facilities in anticipation of regulatory filings and commercialization.
The MannKind inhaled insulin delivery system consists of a proprietary dry powder Technosphere formulation of insulin that is inhaled into the deep lung using a proprietary inhaler which utilizes single-use, disposable plastic cartridges containing Technosphere Insulin powder.
Novel drug delivery techniques like inhalable insulin and inhalable vaccine make it easier for patients or caregivers -- not just doctors -- to administer medications. The powder format travels better and typically requires less stringent refrigeration. In some cases, medicines previously delivered by a doctor's office injection could be delivered over the counter.