FDA action prompts BDSI to develop safety plan for patch.

BioDelivery Services International (BDSI) is taking the precaution of developing a safety plan for its patch designed for cancer patients who suffer breakthrough pain, the "Triangle Business Journal" reported Jan. 11.

Al Medwar, vice president of marketing for Raleigh-based BDSI, said his company's BEMA Fentanyl patch, which delivers pain medication when placed in the mouth, is significantly different than patches that deliver the same medication by being placed on the skin.

Those transdermal fentanyl patches were cited in a December public health advisory from FDA following reports of life-threatening side effects and even death associated with inappropriate prescription or use of the patches. No such risks have been associated with BDSI's patch, which is not yet commercially available.

BDSI's patch delivers the medication more quickly than skin patches, and it dissolves in the mouth, eliminating the need for disposal. Still, BDSI is taking the precaution of developing a Risk Minimization Action Plan, or RiskMAP, for its fentanyl patch.

Fentanyl is a narcotic pain medication more powerful than morphine that has been in use for years. FDA first issued a public health advisory for fentanyl skin patches in July 2005 following reports of the deaths of some patients.

The December advisory says that despite the 2005 warning, FDA continues to hear reports of instances in which doctors inappropriately prescribed the patch for acute pain following surgery or for headaches or mild pain. The patches are intended for patients, such as those being treated for cancer, who experience breakthrough breakthrough pain beyond what other medications can manage.

In other instances, excessive heat, such as a heating pad, accelerated the release of fentanyl, resulting in a dangerous level of the drug in the patient's bloodstream. Medwar says BDSI's heat tests show no significant change in the release of fentanyl.

Anne Trontell, M.D. of the Agency for Healthcare Research and Quality (AHRQ) told the Triangle Business Journal it is too soon to determine how much RiskMAPs have improved drug safety since they were introduced in 2002. But she notes that the information developed in such plans identifies circumstances in which a drug would or would not be appropriate. She cites Lotronex, a drug used to treat irritable bowel syndrome, as an example.

The GlaxoSmithKline drug was linked to some instances of severe intestinal problems and even death. After FDA pulled the drug from the market in 2000, the agency allowed Lotronex to return with restrictions in 2002. Its RiskMAP limits the drug to certain patients and calls for doctors to keep a close watch for problems.

"Although there are some complications, they haven't been in any number and there haven't been any deaths," Trontell said.

BDSI's product, which is about the size of a dime, still awaits FDA clearance. The company filed an NDA with the agency in October that was officially accepted for review on Jan. 10.

By Joseph Pickett, Associate Editor