Insulin without needles may be reality one day

ALACHUA – Daily insulin injections can be a hassle for people with diabetes. Those who dislike needles might have a reason to rejoice, though. In about four years, one company from Alachua hopes to market a new way to deliver injectable drugs such as insulin that doesn't require daily needle injections.

Prometheon Pharma, based out of the Sid Martin Biotechnology Incubator, is developing a patch capable of delivering a wide range of medicine through the skin, similar to a nicotine or estrogen patch.

“I think it has a potential to completely change people’s lives,” said Dr. Stephen Hsu, founder and CEO of Prometheon.

Prometheon aims to make their extended-wear Topiconpatches capable of delivering a consistent dosage of medication for up to seven days. Somebody could put it on one Sunday and change it the next, Hsu said. It would also be more efficient for delivering medication that is metabolized by the liver, he said. When somebody takes oral medication, a significant fraction of the drug could be eliminated by the liver before the drug has a chance to enter the bloodstream. About 40 to 50 percent of insulin normally produced by the pancreas of healthy people is immediately metabolized by the liver.

Hsu believes the patch has a diverse potential beyond delivering just injectable drugs. It could be used to deliver vaccines, chemotherapy or anti-depressants, for instance.  

“We don’t know what the limit of what we can do is,” he said, pointing to gene therapy as one other possible application.

“When you’re depressed, it takes you two hours to get out of bed and brush your teeth, let alone take your drugs,” Hsu said. By making treatment easy and convenient, he believes more people will take and benefit from their medications.

Non-compliance with taking prescribed medication is a huge problem in healthcare, he said. For people with diabetes, only about 60 percent of prescribed injections are actually done, he said.

“It’s inconvenient, it’s painful, it's easy to forget” Hsu said. “People hate needle injections. The convenience of a simple patch will lead to higher compliance.”

Prometheon decided to tackle insulin as the first application of the patch.

“We have this huge global epidemic of obesity and diabetes,” Hsu said, making the choice of which drug to first utilize the patch for obvious.

Unlike injectable insulin, the TopiconDM insulin patch would not need to be refrigerated, improving access to the medicine in developing countries without reliable electricity or refrigeration. The medicine is stored on the patch as a solid, but melts into a gel only when warmed by the wearer’s body temperature. Hsu is working on a heat-resistant patch for use in much warmer climates.

The company is making every effort to make all Topicon patches biodegradable and eco-friendly, he said. Any remaining medicine in the patch can be rinsed off with hot water in the sink so that the drug-free patch can be safely discarded.

“There are stories of children who pick their parents' discarded patches out of the garbage,” Hsu said. “The children imitate their parents and put the patch on, and then they die.”  

The problem in the past with getting a patch like this to work has been that the molecules for most medications are too large to be absorbed through the skin, he said. Hsu said he has found a way to make it work, but cannot go into detail while the patent is still pending.

Prometheon has already tested the Topicon DM patch on diabetic rats with success, he said. The next step is using pigs. Because it is a delivery device for already FDA-approved drugs and generics, the regulatory approval process will be much shorter than it is for bringing a new drug on the market.

Hsu plans on the patch being on the market in early 2018. He believes the improved access to affordable vital drugs and convenience of the product will bring about a healthier world.

“Ultimately, that translates into better quality of life,” he said.         

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