FDA accepts Intarcia’s NDA for diabetes drug-device combo

Intarcia Therapeutics said today that the FDA accepted its New Drug Application for the 1st drug to use Intarcia’s Medici drug delivery system to treat Type II diabetes. The Medici drug-device combo delivers exenatide subcutaneously using a match-sized osmotic pump placed under the skin in an in-office procedure.

The subcutaneous delivery system uses technology to stabilize proteins, peptides, antibody fragments and other small molecules at or above human body temperatures for up to 3 years. Once the mini-pump is placed under the skin, water from extracellular fluid enters the device at 1 end, diffusing through a semi-permeable membrane into a salt osmotic engine and expanding to drive a piston at a controlled rate to release the drug within the pump from the other end.

Get the full story at our sister site, Drug Delivery Business News.

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