Biopharmaceutical giant Pfizer Inc. said it received a Complete Response Letter from the U.S. Food and Drug Administration, rejecting the new drug application for its investigational pain relief drug Remoxy Extended-Release Capsules CII, developed by Pain Therapeutics, Inc. Remoxy was using Oradur drug delivery technology developed by Durect Corp. Subsequent to the announcement, the shares of Pain Therapeutics and Durect plunged.

Remoxy is an investigational abuse-resistant, long acting, oral painkiller containing narcotic oxycodone intended for moderate-to-severe chronic pain. It is an encapsulated, water insoluble, twice-daily oral formulation.

Commenting on the rejection, Pfizer said it is working to evaluate the issues and plans to have further discussions with FDA around them.

Olivier Brandicourt, Pfizer President and General Manager, Primary Care said, “Pfizer is working to understand and address the issues in the FDA Complete Response Letter. Pain is an important strategic disease area for Pfizer. We share the concern about misuse and abuse of opioid medicines and are committed to being part of the solution to address this important public health and safety issue.”

James Brown, president and CEO of Durect noted that Pfizer has an experienced team of scientists dedicated to resolving the remaining issues.

Pain Therapeutics had submitted the initial new drug application for Remoxy in June 2008, however, it was rejected by FDA in December that year, requesting for more data. Later, Tennessee based King Pharma assumed the control of the drug and filed a resubmission in December 2010, further to an abuse liability study. When Pfizer acquired King Pharma, in February 2011, it received the rights to Remoxy.

In April end, Pain Therapeutics announced that an abuse liability study of Remoxy met all primary endpoints. The study recorded that patients on Remoxy showed lower liking for the drug compared with standard care oxycodone and placebo.

DRRX shares are trading down 30.42 percent at $2.16 on a volume of 1.29 million shares, while PTIE is down 39.50 percent at $5.5701 on a volume of 6.77 million shares.

PFE shares are currently trading at $20.28, down 1.84 percent on a volume of 12.44 million shares.

Technorati Tags: FDA, Pain Killer, Pfizer, Remoxy

ADELPHI, Md. – Government experts say prescription drugs like Vicodin and Percocet that combine a popular painkiller with stronger narcotics should be eliminated because of their role in deadly overdoses.

A Food and Drug Administration panel on Tuesday voted 20-17 that prescription drugs that combine acetaminophen with other painkilling ingredients should be pulled off the market.

The FDA has assembled a group of experts to vote on ways to reduce liver damage associated with acetaminophen, one of the most widely used drugs in the U.S.

Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., according to the FDA.

Panelists cited FDA data indicating 60 percent of acetaminophen-related deaths are related to prescription products. Acetaminophen is also found in popular over-the-counter medications like Tylenol and Excedrin.

“We’re here because there are inadvertent overdoses with this drug that are fatal and this is the one opportunity we have to do something that will have a big impact,” said Dr. Judith Kramer of Duke University Medical Center.

But many panelists opposed a sweeping withdraw of products that are so widely used to control severe, chronic pain.

“To make this shift without very clear understanding of the implications on the management of pain would be a huge mistake,” said Dr. Robert Kerns of Yale University.

In a separate vote, the panel voted overwhelmingly, 36-1, that if the drugs stay on the market they should carry a black box warning, the most serious safety label available.

The FDA is not required to follow the advice of its panels, though it usually does.

Prescription acetaminophen combination drugs were prescribed 200 million times last year, according to FDA data. Vicodin is marketed by Abbott Laboratories, while Percocet is marketed by Endo Pharmaceuticals. Both painkillers also are available in cheaper generic versions.

The FDA convened the two-day meeting to ask experts to discuss and vote on a slew of proposals to reduce overdoses with acetaminophen. The drug has been on the market for about 50 years and many patients find it easier on the stomach than ibuprofen and aspirin, which can cause ulcers.

Earlier in the day, panelists took aim at safety problems with Tylenol and dozens of other over-the-counter painkillers. In a series of votes, the panel endorsed lowering the maximum dose of those products.

FDA’s experts voted 21-16 to lower the current maximum daily dose of nonprescription acetaminophen, which is 4 grams, or eight pills of a medication like Extra Strength Tylenol.

The group was not asked to recommend an alternative maximum daily dose.

The panel also voted 24-13 to limit the maximum single dose of the drug to 650 milligrams. The current single dose of Johnson & Johnson’s Extra Strength Tylenol is 1,000 milligrams, or two tablets.

In a third vote, a majority of panelists said the 1,000-milligram dose should only be available by prescription.

However, panelists rejected a proposal to pull certain cold and cough medicines off the market because of their role in overdosing.

The drugs in question, such as Procter & Gamble’s NyQuil or Novartis’ Theraflu, combine acetaminophen with other ingredients that treat cough and runny nose.

The FDA says patients often pair the cold medications with pure acetaminophen drugs, like Tylenol, exposing themselves to unsafe levels of the drug.

But panelists cited FDA data that said the medications play a minor role in acetaminophen overdoses, with only 10 percent of acetaminophen-related deaths involving a cold and cough product.

“I don’t think we should be advocating a solution to a problem that really is not there,” said Dr. Osemwota Omoigui, of the Los Angeles pain clinic.

The panel voted 24-13 to keep the products on the market.

Technorati Tags: acetaminophen drugs, FDA, medications, painkillers, prescription drugs, tylenol