Terrified of needles? Help is on the horizon
A Franklin company will begin selling a futuristic device next month that painlessly injects medications through microscopic pores in the skin -- holes created by low-frequency vibrations instead of high-anxiety needles.
The hand-held, ultrasonic device applies sound waves to the skin for 15 seconds, disrupting a protective membrane to allow fluids to flow in or out. The openings allow larger molecules, including those of many drugs, to pass through quickly. After 24 hours, the skin returns to normal.
Called SonoPrep, the $2,000 device was approved Tuesday by the US Food and Drug Administration, its manufacturer, Sontra, announced yesterday. For now, it will be used to quickly anesthetize skin with lidocaine cream -- in five minutes instead of the current one hour -- to prepare patients, especially children, for painful procedures, including needle pricks and the insertion of catheters and IVs.
But company officials said they are developing other applications, including fast administration of pain medications to cancer patients, dispensing flu vaccines, and continuous monitoring of diabetics' blood sugar levels.
The product, invented in the laboratory of MIT bioengineer Robert Langer, is at the leading edge of technology being developed to deliver medicine painlessly, more efficiently, and in a more targeted way than pills. Researchers say these efforts could make needles obsolete in medicine.
"The important point, to me, is not just that the FDA approved it -- it's a validation of the technique," Langer said. "It opens the door to all kinds of needle-less injections. . . . It's kind of like 'Star Trek.' They zap people, and the stuff goes through."
An explosion of drug-delivery techniques has produced many patents and FDA applications in the last decade. Langer has had great success with an implanted wafer he designed to slowly release cancer drugs at the site of a brain tumor. A needle-free insulin injector, called Injex and made by
Sontra was founded in 1996 by Langer and MIT colleagues Joseph Kost and Daniel Blankschtein, with former MIT graduate student Samir Mitragotri, to commercialize the SonoPrep device.
"It's incredibly promising," said Dr. Charles Berde, director of Pain Treatment Services at Children's Hospital. "I see it as a methodology of getting a variety of other drugs across the skin."
Berde thinks the treatment could "get around delays" associated with blood work and could be especially useful for children who have had a lot of needle procedures and are afraid of them.
"Even when you tell them it won't hurt, their response is, 'Why should I believe you?' " Berde said. While this pain-free technique will not cure fear of needles in one use, Berde said it could be valuable in the long term.
Berde said SonoPrep's initial success probably would depend on whether hospitals would be willing to pay $2,000 for the ultrasound unit, but Sontra officials said the cost would be recouped if the unit is used frequently.
"The hospital will pay no more than it does for a single use of lidocaine today," said Sean Moran, the company's chief financial officer.
Sontra plans to test SonoPrep to administer painkillers as well, specifically the opiate fentanyl that is often used for cancer patients. Now, it takes 18 hours for enough fentanyl to get into the bloodstream that the brain can perceive it as a painkiller. Moran said they may be able to significantly reduce that time.
"It could help people whose problems with pain are unpredictable," said Janet L. Abrahm, director of the Pain and Palliative Care program at the Dana-Farber Cancer Institute. "If the pain is constant, we're able to pretty much match the medication with that pain. For people whose pain levels get much worse suddenly, we need something more flexible."
The company will begin human studies this fall using the device to deliver flu vaccine, Moran said.
SonoPrep is Sontra's first commercial product, and after the FDA's approval, the company's stock soared yesterday. It gained 51.4 percent, to close at $2.15. This milestone is a far cry from Sontra's woeful financial status 15 months ago, when the company had less than $1 million on hand, enough to stay in business only about two more months. "That was a tough time for Sontra," Moran said.
Since then, Sontra has entered into a development agreement with Bayer Diagnostics for a needle-free, continuous glucose monitor, using the SonoPrep technology. Bayer has 20 percent of the $5 billion glucose monitoring market. Sontra officials hope to have FDA approval for a continuous glucose monitor by 2007 or 2008.
Jessica T. Lee can be reached at jtlee@globe.com.
