Implanted Microchip Delivers Meds Remotely
The drug delivery device (on right) next to an everyday computer memory stick.
CREDIT: MicroCHIPS, Inc., Massachusetts
An implantable microchip has been shown for the first time to be able to safely and efficiently deliver a drug dose to patients. The achievement could help overcome concerns about patients’ abilities to stick with a difficult regimen of an injectable drug.
“This is the first human study where an implanted electronic device has been responsible for the preprogrammed delivery of a drug,” said Michael Cima, a professor of engineering at MIT and one of the microchip’s inventors. “I think it’s the leading edge of what implanted electronics could become.”
The chip was implanted in eight postmenopausal women with osteoporosis (a 30-minute procedure) and used for a 20-day course of dosing of human parathyroid hormone fragment (hPTH), a medication that would otherwise be injected daily. The chips were implanted for four months total, with dosing not started right away, to ensure that proper amounts of medicine would be dispensed even after spending some time in the body beforehand.
Seven patients completed the study, with the follow-up showing the same results as if they had injected the drug daily during the study period (the eighth patient’s microchip did work properly and did not release the drug during the study).
The microchip’s development began about 15 years ago in the lab of MIT professor Robert Langer. MicroCHIPS Inc., the company developing the product, was founded in 1999.
Robert Farra, president and chief operating officer of MicroCHIPS and first author on the study, said osteoporosis was chosen as the first test for several reasons. Its doses are small enough to fit in a microchip, it needs frequent administration and it needs to be dispensed in a pulsatile manner — continuous release would actually degrade the drug and harm the patient.
“Treating osteoporosis with parathyroid hormone right now is a 24-month regimen,” he said, explaining that only 25 percent of patients stick with the daily injections for that period.
In the future, he said, drugs with a similar schedule and administration will be looked at, such as drugs for IVF treatment and dosing of interferon for patients with multiple sclerosis.
The hope, Farra said, is to have a product in the marketplace in four years. That encompasses two years to develop a chip carrying 365 doses and another two years for FDA approval.
Farra said the cost of the device with medication is going to be set to match the current cost of administration of the drug. Health care savings from the device would come in the form of better compliance, improved outcomes for patients and a reduced cost for managing patients.
“I would really be enthusiastic about this type of approach, and certainly having it on the market down the line I think would be an advance for women with severe disease,” said Dr. Felicia Cosman, senior clinical director for the National Osteoporosis Foundation.
She cautioned that “I’m sure some people will have concerns about having a device implanted,” and noted they may opt for other options being explored, such as oral drugs or transdermal patches.
But, Cosman said, “One of the main impasses to initiating and continuing this therapy is the need to inject it daily. The ability to have something that is easily implantable and safely implantable that can avoid the need to inject daily I think is a potential boon for people with osteoporosis.”
The study was published online today (Feb.16 ) in the journal Science Translational Medicine and was presented today at the meeting of the American Academy for the Advancement of Science.