Fentora

FDA blocks new Fentora uses

Tracy Staton — Tue, 16 Sep 2008 11:01:28 -0400

The FDA to Cephalon: Get a better risk-communication program. That's what lies between the drugmaker and new indications for its painkiller Fentora. As you know, Fentora is already emblazoned with warnings of potentially life-threatening risks. Cephalon has reported five deaths among Fentora patients, from adverse reactions or overdose.

Already approved for breakthrough cancer pain, Fentanyl was up for FDA consideration to treat breakthrough pain in patients with chronic lower back and nerve pain. But an advisory panel voted 17-3 against broadening the use of Fentora, citing the potential for misuse among even more patients.

The company said it will continue to educate caregivers and patients to make sure the drug is appropriately prescribed--but offered no other word yet on how it plans to answer the FDA's concerns. Though the drug was introduced only under strict guidelines for use, in its some two years on the market, scrips have grown to the point that more than 80 percent of patients take it off-label.

- read the story in the Philadelphia Inquirer

FDA panel rejects broader Fentora use

Wed, 07 May 2008 06:59:57 -0400

No go, Fentora. An FDA advisory panel voted against broadening the use of Cephalon's painkiller, citing worries that it would in fact be misused. Already the potent drug has caused overdoses and death when it was improperly substituted for another painkiller. Plus, the panel said it could be more attractive to potential abusers because it's stronger than other opioids. The expert advisers told Cephalon to get more data on a proposed risk-management plan for the drug.

The FDA doesn't have to follow the panel's recommendations, but usually does. And an FDA briefing document raised these concerns in advance of the panel meeting. A final decision is expected in mid-September. If the FDA decides to go ahead and approve the expanded label, Fentora could have a potential market of more than 10 million patients, the panel estimated.

After yesterday's meeting, analysts said even if Fentora doesn't get the FDA go-ahead this time around, the drug may still be approved for broader use: It's "a matter of when--not if," one said.

- see Cephalon's release
- see the story in BusinessWeek
- check out the AP article

ALSO: The FDA's decision to reject Merck's new cholesterol med Cordaptive is further proof that the agency is remaining cautious, according to the Star-Ledger. Report

Expert panel to mull broader Fentora use

Fri, 02 May 2008 06:59:55 -0400

Everyone suddenly has an opinion on Fentora. Good opinion: The Cephalon painkiller got European approval a couple of weeks ago, after two years on the market in the U.S. Another good opinion, in the imitation-is-flattery department: Watson Pharmaceuticals filed for the FDA OK on its copycat version of the oral med. In good opinion number three, analysts pooh-poohed Watson's generic challenge, saying, "Fentora is a novel invention and the patents are strong."

Then there's one not-so-sure opinion, from none other than the FDA. As the anesthetic drug advisory committee prepares to discuss broadening usage of Fentora at next week's meeting, an agency staffer raised the twin specters of drug abuse and adverse events in briefing documents. Fentora's current risk-management programs have already failed in a few instances, the documents state, leading to serious adverse events, including overdose deaths. You'll recall that the company strengthened warnings on Fentora's label to help prevent those problems, which seem to stem from prescribing the med inappropriately and from substitution errors.

Given these problems, the documents say, expanding Fentora's indication beyond breakthrough cancer pain could lead to more misuse. And it could make the med more accessible to potential abusers. Key to approval, the staffer wrote, would be an effective risk management program. Is this possible? We'll see what the advisory committee says next week.

- read the FDA briefing
- see the Euro OK piece at Motley Fool
- check out Watson's release
- read the patent coverage in the Chester Daily Local

10. Fentora - Top 10 Warnings and Recalls

Tracy Staton — Thu, 29 Nov 2007 10:17:50 -0500

Drug: Fentora

2006 sales: $370 million

Manufacturer: Cephalon

Safety concern: Warning; improper dosing leading to death

Related Articles:
> New warning for off-label Fentora. Report
> Red flags raised on Fentora misuse. Report
> FDA approves Fentora for cancer pain. Report
> Cephalon shares jump on Fentora decision. Report
> Cephalon takes heat for off-label narcotic promotion. Report

New warning for off-label Fentora

Thu, 27 Sep 2007 06:59:56 -0400

The FDA issued a warning yesterday on Fentora, the Cephalon painkiller recently linked to three deaths. All three stemmed from off-label use of the fentanyl drug, which is approved only for treatment of breakthrough cancer pain.

Cephalon had warned doctors two weeks ago of the risk of fatal overdose with Fentora. But the company may have played a role in pushing off-label prescriptions. Since 2004, Cephalon has drawn scrutiny from state and federal prosecutors, and from a Congressional oversight committee, for allegedly promoting off-label uses of several drugs, including Fentora.

- see the FDA warning
- read the article from the Philadelphia Inquirer

Related Articles:
Red flags raised on Fentora misuse. Report
FDA approves Fentora for cancer pain. Report
Cephalon shares jump on Fentora decision. Report
Cephalon takes heat for off-label narcotic promotion. Report

Red flags raised on Fentora misuse

Fri, 14 Sep 2007 06:59:58 -0400

Pain can be a killer. Cephalon officially warned doctors yesterday to use its opioid pain reliever Fentora very, very carefully, or patients might die. Some already have, while others have experienced severe side effects--but only because of improper dosing or substitutions, or because they should never have been given opioids in the first place.

Cephalon said Fentora should only be used for cancer patients already using other opioids like morphine or another fentanyl product--not for post-op pain, migraines, sports-injury pain, and the like. And Fentora isn't a substitute for other fentanyl products. Investors reacted quickly to the news, sending shares down by more than 4 percent in double its usual daily trading volume.

- check out this release
- here's the report from SmartMoney

Related Articles:
FDA approves Fentora for cancer pain. Report
Cephalon shares jump on Fentora decision. Report
Cephalon takes heat for off-label narcotic promotion. Report