AUSTIN, Texas—A breakthrough system that delivers insulin to diabetics without using needles is being developed by researchers at The University of Texas at Austin and DelRx, a New Jersey pharmaceutical company. Roughly similar to an inhaler, the system is ready for large-scale clinical trials, according to Dr. Bill Williams, associate professor in the College of Pharmacy.
“This takes the needles out of insulin. It’s very exciting,” Williams said. “To have a painless administration of insulin would be a major breakthrough. Kids or adults — no one wants to have to inject.”
Williams said the delivery system has been successful when administered to animals. The next step is testing on human subjects and seeking approval from the U.S. Food and Drug Administration. A peer-reviewed paper outlining the research will be presented Tuesday (Nov. 16) in New Orleans at a meeting of the American Association of Pharmaceutical Scientists.
Williams explained that DelRx, of Jamesburg, N.J., has “a novel composition containing insulin in combination with a novel delivery route through the inside of the cheek. It is called transmucosal delivery. You spray this device that looks like an inhaler into the mouth — aiming it at the cheek area. The insulin is deposited on the buccal membrane.”
DelRx is a subsidiary of MQS, Inc. which funded the two-year research project. Dr. Miles Libbey, DelRx President, said: “We are still very early in this, but it has worked well in animal models. We believe the system will have wide application for insulin dependent diabetics.”
Libbey said he became interested in an easier delivery system in the mid-1970s after his 9-year-old son, Benjamin, was diagnosed with juvenile Type II diabetes. Dealing with diabetes is hard on both parents and children.
“It was a heart breaking experience to find out that your child has a disease that, in all likelihood, he will have to live with all this life. That is compounded when you are preparing needles for your child several times a day,” Libbey said.
Until recently, Type 2 diabetes has largely been diagnosed in adults over the age of 40. However, a growing number of children are showing evidence of Type 2 diabetes. The disease also is an epidemic among Mexican Americans in Texas. The chronic disease can have very serious side effects, including blindness and problems with the feet, sometimes leading to amputation. Medication and changes in exercise and diet can reduce complications that often result from the disease.
Williams explained that better control and more convenience are two major benefits to the system. First, instead of having to inject insulin, a diabetic would be able to control blood glucose level with a certain number of puffs into the mouth. “What the company envisions is that patients would be able to use this spray multiple times throughout the day so they can better control the blood glucose level,” Williams said.
Diabetics need to take a short acting insulin before each meal to control the glucose increase caused by the meal. Then the insulin should stop acting. Williams said the new system may prove superior to some of the current, short-acting, injectable insulin products taken before meals, because the effects of those products may last too long, overlapping with the next meal.
Convenience also is a benefit. At present, injectable insulin must be refrigerated.
“What we have come up with in collaboration is a delivery system that is stable at room temperature. This inhaler device does not have to be stored in a refrigerator, which makes it very convenient for patients,” Williams said.
Libbey said taking needles out of the process and making application more convenient should mean that patient compliance with medical requirements increases as well, leading to better results. It’s uncertain how soon the device could be made available on the market to the nation’s 16 million diabetics.
“We’ve had preliminary discussions with the U.S. Food and Drug Administration on our path toward the market and we are very encouraged by their preliminary reaction,” Libbey said. “Our initial filing with the FDA takes place before end of the year. We are actively looking for support in the venture capital community.”
Williams cited the development as a good example of the ways the private sector can work with a public institution. “This is a beautiful example of collaboration between a pharmaceutical company and a university,” said Williams, who has taught at UT Austin for the past five years. “We get research money and their ideas and they get their product concept. It’s a win-win for both the university and for the company.”
For more information, contact Dr. Bill Williams at (512) 471 4681 or Dr. Miles Libbey at (732) 656 0300.