FDA Approves Insulin Patch-Pen for Use With Insulin Aspart
July 27, 2010 — The US Food and Drug Administration (FDA) has granted 510(k) clearance to market an insulin patch-pen (Finesse; Calibra Medical, Inc) for up to 3 days' use with rapid-acting insulin aspart (NovoLog; Novo Nordisk, Inc).
The bolus-only flat patch-pen is small (2" × 1" × 0.25") and contains a 200-unit reservoir from which insulin is delivered through a plastic tube inserted into the skin. Worn on the skin like a bandage, the device can be discretely activated through clothing by squeezing together 2 buttons, providing mealtime, snack time, and correction bolus insulin in seconds.
"Finesse will be easy for physicians and diabetes educators to explain to patients. Most patients want to eliminate the social embarrassment, elaborate preparation before each dose and the many daily needle sticks required by syringes and insulin pens," said Jeffrey L. Purvin, Calibra Medical's chairman and chief executive officer, in a company news release. "Like expensive insulin pumps, Finesse provides fast, discreet, needle-free dosing. Yet, it accomplishes this with the simplicity, safety and affordability of syringes or insulin pens."
To be effective, insulin must be administered in certain amounts at prescribed times in a regimen that is often inconvenient. Use of the patch-pen device may enhance therapeutic compliance, thereby avoiding long-term complications such as nerve damage, blindness, heart disease, and kidney impairment.
"With this device people will find daily self-administration of multiple doses of insulin is far easier, with less disruption and increased potential for better diabetes control," said Nancy J. V. Bohannon, MD, in the news release. Dr. Bohannon is a practicing endocrinologist and director of clinical research at the Cardiovascular Risk Reduction Program, St. Luke's Hospital, San Francisco, California, and also served as the principal investigator for the recently completed feasibility clinical trial at 5 leading diabetes clinics in the United States.
The patch-pen device previously was approved for use with insulin lispro (Humalog; Eli Lilly & Company, Inc).