FDAnews Drug Daily Bulletin

Answer to Chronic Pain Treatment May Still Lie in Drug Patches

Aug. 26, 2008

Treating chronic pain with drugs in skin patches offers extended relief, so several companies are addressing known risks by using new patch technology to deliver drugs more safely.

A patch design from Mylan called the Fentanyl Transdermal Drug Delivery System, which the FDA approved in 2005, seems to have conquered the problem of leaks of medicine that caused recalls of other skin fentanyl patches. In Mylan’s device, the drug is in the adhesive instead of being enclosed in a pouch of liquid as found in reservoir patches. The company’s Fentanyl Transdermal System (C-II) is flat and thin.

Mylan is the only company that markets the matrix fentanyl patch in the U.S. and hasn’t had a recall due to leakage, and that is because the matrix design cannot leak, company spokesman Michael Laffin said.

Steven Damon, Altea Therapeutics’ vice president of business development, said that his company is studying an approach using fentanyl citrate, the salt form of fentanyl, which stays in the patch.