FDA panel rejects Cephalon pain drug on risks of misuse
Tuesday May 6, 4:59 pm ET
By Matthew Perrone, AP Business Writer
FDA panel votes against wider approval for Cephalon pain pill, citing risks for abuse
WASHINGTON (AP) -- Medical experts on Tuesday voted against allowing a powerful painkiller made by Cephalon Inc. to be marketed for uses beyond treating pain in cancer patients, saying it could worsen existing misuse of the drug that has caused overdoses and death.
Cephalon's drug Fentora is already approved to treat severe pain flare-ups in cancer patients already taking opioids, a type of prescription painkiller. The company wants Food and Drug Administration approval to market the drug for chronic pain not caused by cancer, a broader market that includes patients with back and nerve pain.
An FDA panel of outside experts voted 17-3 against wider use of the drug. The agency is not required to follow the panel's advice, though it usually does.
Panelists questioned the need for such a powerful pain medication for noncancer patients, given narcotics already on the market.
"How many people are we going to help with the release of this product and how many are we going to hurt?" asked panel member Dr. Charles Cortinovis, of the Veterans Administration Hospital in Pittsburgh. "In my mind it is very scary to release such a large amount of powerful opiate into the American population."
FDA scientists said Tuesday that widening approval of the drug could have dangerous effects because of the risks for improper prescribing and abuse of the drug, which is more potent than other pain medications.
Fentora was approved in 2006 under strict guidelines meant to ensure it was only used by cancer patients already taking other opioid drugs for pain. Since then, FDA said prescriptions for the drug have increased fivefold, with more than 80 percent of patients taking the drug "off-label," or for unapproved uses.
Doctors are allowed to prescribe medications for off-label uses, though companies cannot promote them.
Cephalon has reported five patient deaths due to negative reaction or overdose on the drug.
The company argued that since Fentora is already being prescribed for unapproved uses, expanding its FDA-approved indication would help ensure it is being used safely.
Currently about 20,000 U.S. patients take the drug. Panelists said expanding its use to noncancer patients could broaden use to more than 10 million patients.
Panelists praised a new plan proposed by Cephalon that would require pharmacists to electronically confirm a patient's symptoms before dispensing the drug.
"The company is doing the responsible thing to do when you find out your drug is only treating 20 percent of patients it's intended for, and being used off-label 80 percent of the time," said Frank Vocci, director for drug abuse at the National Institutes of Health.
Most panelists said, however, that the company must perform more studies to prove its plan will help reduce medication errors and abuse of the drug.
Fentora is part of the opioid class of prescription painkillers, which also includes morphine and codeine. The drugs can be highly addictive and are sometimes abused for their euphoric effects, which are similar to those of heroin.
Because Fentora is more potent than other opioids, the FDA said it could be more attractive -- and dangerous -- to potential abusers.
But Cephalon rejected this notion, pointing to studies by Columbia University researchers that showed its drug was no more attractive to heroin addicts than other narcotics.
FDA is expected to make its final decision on the drug by mid-September.
Even if FDA rejects Cephalon's request, analysts do not expect it to significantly harm the company's earnings outlook. Fentora accounted for just 8 percent of the company's total revenue last year, or $137 million.
Friedman, Billings, Ramsey analyst David Amsellem expects Fentora to grow to $161 million by 2012, but remain at 8 percent of the company's total sales. Most of the company's recent growth has come from sales of its narcolepsy drug, Provigil, which accounted for half of its 2007 revenue.
surf's up......crikey
