May 7, 2008 - FDA Advisory Panel Votes Against Expanded Approval for Fentora
An FDA panel voted 17-3 yesterday against drug maker Cephalon Inc.’s bid to expand approval for its narcotic painkiller Fentora. Fentora is a fast-acting form of Cephalon’s Actiq, which is sold as a berry-flavored lozenge on a stick. Both Fentora and Actiq are currently approved by the FDA for use in cancer patients with chronic severe pain. The active ingredient in each drug is fentanyl, a highly addictive narcotic estimated to be 80 times more powerful than morphine, and classified by the DEA as a schedule II drug along with cocaine, heroine and amphetamines. Schedule II classification is reserved for drugs with a high potential for abuse and increased risk of fatal overdose.
Panel members voiced concerns about approving the expanded use of Fentora because of its highly addictive nature. In addition, the drug is currently linked to at least 120 overdose deaths, including two children. About 20,000 people in the U.S. currently use Fentora, but FDA officials estimate that if they were to approve use beyond cancer patients, that number would quickly reach as many as ten million. Fentora received initial approval in 2006, for cancer patients who experience “breakthrough pain” as the result of a built up tolerance to other narcotic analgesics.
Although approved strictly for cancer patients, it is known that as many 80 percent of people using Fentora do so “off-label,” for headaches and back pain. Once a drug has received FDA approval, doctors are free to prescribe it as they see fit, but drug companies are legally barred from promoting the drug for any uses that have not specifically received the FDA’s approval. Cephalon Inc. has been the subject of several investigations into alleged off-label promotion of Fentora and other narcotic painkillers. In November of last year, the company reached an agreement with the US Department of Justice to pay $425 million in order to settle charges stemming from illegal marketing of both Fentora and Actiq.
In September 2007, after Cephalon reported five Fentora-related deaths from either overdose or adverse reaction, the FDA issued a public health advisory, warning that several Fentora-related deaths had occurred in patients who were prescribed the drug for off-label use. The FDA advisory warned that Fentora should not be used for any other conditions including migraines, post operative pain and pain due to injury.
Despite the overdose dangers, Cephalon has continued to push the FDA to expand Fentora’s approved uses. At yesterday’s advisory panel meeting, however, FDA scientists testified that widened approval of Fentora could have dangerous results because of the risks of improper prescribing by physicians and abuse by patients. for improper prescribing and abuse of the drug, which is more potent than other pain medications.
Patients suffering from back pain and migraines already have access to many approved narcotics, causing many panelists to question the need for expanded Fentora approval. One panel member, Dr. Charles Cortinovis, of the Veterans Administration Hospital in Pittsburgh, said that such approval would be releasing a large amount of powerful opiates to the American population, which in his mind, he said, “is very scary.”
Cephalon tried to ease fears over the potential misuse of Fentora by proposing a plan that would require pharmacists to electronically confirm a patient’s symptoms before dispensing the drug. While some panelists like that idea, they want Cephalon to perform more studies to prove its plan will help reduce medication errors and abuse of the drug. Several panel members also said Cephalon should conduct more studies to determine whether Fentora offers more benefits to non-cancer patients than other painkillers already approved for such uses.
The FDA is expected to make its final decision on Fentora by mid-September. Though the agency is in no way bound to follow the recommendations it receives from advisory panels, it most often does.
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