FDA OKs New Cancer Pain Drug

Sept. 27, 2006 -- The FDA has approved Fentora, a new prescription drug, to treat severe, brief pain flare-ups ("breakthrough pain") in cancer patients who are already taking opioids for underlying, persistent cancer pain.

Fentora contains fentanyl, an opioid. The FDA approved Fentora on Sept. 25.

Cephalon, the drug company that makes Fentora, expects Fentora to be available in the U.S. starting in the first week of October, according to a Cephalon news release.

The drug comes in tablets, but those tablets aren't swallowed. Instead, they're placed in the mouth, between the upper cheek and gum, above a rear molar tooth.

Saliva helps the tablets dissolve and quickly pass into the body. The medicine enters the bloodstream faster than if the pills were swallowed and sent through the digestive system, according to Cepahlon.

Fentora is the first pain medicine in seven years to be approved for the management of breakthrough pain in cancer patients. It's also the first tablet of its kind, says Cephalon.

Other pain medications can take 30 minutes-45 minutes to take effect, but some patients in Fentora's clinical trials had pain relief within 15 minutes, according to Cephalon.

Fentora was "generally well tolerated" in clinical trials, states Cephalon.

Fentora's most common side effects in clinical trials were nausea, vomiting, abnormalities at the application site, fatigue, anemia, dizziness, constipation, swelling, weakness, dehydration, and headache.

Most side effects were mild to moderate in severity and were typical of opioid drugs, according to Cephalon.