DrugBuyers.Com: Generic Oxycontin approved

The FDA approved Teva and Endo to make generic OxyContin yesterday. Hopefully they will get things settled fast with Purdue who is still arguing they have the exclusive patent. They might start offering the generic med. prior to settling the patent case, however, which should help bring the price down and make time released Oxycodone more widely available and perhaps less stigmatized.

Here's an article from today's Wall Street Journal talking about this medication, the approval of the generic yesterday, and also some other pain meds in the pipeline.

Since it's med-related talkin extensively about OxyContin and other pain meds I posted this on the meds board rather than the news board. Feel free to move it mods...

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March 24, 2004

FDA Approves Generic OxyContin
Teva, Endo Get Clearance
After Agreeing to Implement
Abuse-Reduction Programs
By ANNA WILDE MATHEWS and LEILA ABBOUD
Staff Reporters of THE WALL STREET JOURNAL

In a closely watched test case for how regulators will handle the risks posed by potent opioid painkillers, the Food and Drug Administration approved the first generic versions of the controversial drug OxyContin.

The approval came with an agreement by the two generic-drug makers to create programs to reduce the risk of abuse and diversion onto the "street" market. The FDA said those "risk-management plans" would be consistent with measures taken by Purdue Pharma LP, the maker of branded OxyContin, which put additional safeguards into place after widespread abuse of the drug opened the company up to criticism as well as lawsuits.

Peter J. Pitts, the FDA's associate commissioner for external relations, said the agency didn't believe that the availability of generic versions would increase demand for the drug, based on the pattern with past generic introductions. Mr. Pitts said the generic versions may cut the cost for legitimate patients. "FDA's job is to maximize potential benefits patients receive and minimize risks due to the products," he said.

Law-enforcement officials have long been concerned about the potential for a bigger, cheaper, less well-controlled supply once versions of OxyContin are marketed by multiple companies. OxyContin has become a high-profile example of the risks posed by powerful painkillers. Originally approved in 1995, it had a special mechanism that allowed the painkiller, chemically known as extended-release oxycodone hydrochloride, to be released gradually over many hours for management of severe pain. But by crushing the pill and snorting or injecting the powder, abusers found they could get all the effects of the drug at once, for a potent high.

Teva Pharmaceutical Industries Ltd. and Endo Pharmaceuticals Holdings Inc., the two generic companies that got FDA go-ahead, declined to immediately comment on their abuse-prevention safeguards. Because both companies are still locked in a legal battle over patents with closely held Purdue Pharma, it isn't clear when they might actually begin selling their cheaper versions. The generic companies said it was too early to talk about pricing.

OxyContin's sales rose to $1.9 billion last year, from $1.6 billion in 2002, according to data from IMS Health. Including OxyContin, sales of narcotic painkillers were $5.6 billion last year, up 20% from the year before, and 127% from 1999, according to IMS Health, a market research company.

The debate over control of such powerful drugs is ramping up because of an expected flood of new painkiller products. Among those in the pipeline are asthma-style inhalers that could administer morphine and fentanyl, a synthetic opioid. Johnson & Johnson, which makes the Duragesic fentanyl patch, has said it hopes to sell other painkilling patches.

The FDA is already moving to push companies to create proactive anti-abuse plans for all new potent painkillers. But as it moves forward, the agency is trying to strike a delicate balance. Many researchers and pain doctors argue that patients with severe pain often don't get the drugs they need. One major 1998 study of 13,625 nursing-home cancer patients found that more than a quarter of those who suffered daily pain got no analgesic at all. Moreover, pain doctors have complained that aggressive law-enforcement efforts may discourage legitimate prescriptions for patients who need potent opioids, which are narcotic drugs with effects similar to those of drugs derived from opium.

On the other side, law-enforcement officials have said they need tough measures to avoid abuse and addiction and trafficking.

About 1.9 million people had at some point used OxyContin without a medical need, according to a 2002 federal study on abuse of prescription painkillers, which also found that an estimated 29.6 million people had at some point used painkillers without a medical need.

The Bush administration recently announced a major crackdown on abuse of prescription drugs, particularly highly addictive painkillers. The Drug Enforcement Administration in the past has called for limits on the distribution of potent and easily abused drugs to certain pharmacies or physicians. But the FDA has never limited any opioid to certain pharmacies, and agency officials say they don't have the authority to block certain physicians from prescribing a drug.

As the problems of OxyContin abuse became more evident, Purdue several years ago began putting in place a number of measures designed to reduce abuse of OxyContin. The program's measures include a national system that is supposed to help track diversion with the goal of informing law enforcement officials of signs of problems. The company also conducts education efforts among doctors and community officials, and offers tools to limit diversion such as special prescription pads for doctors.

Still, it can be hard to accurately gauge the effects of such programs, partly because it is difficult to measure the extent of abuse.

Purdue has said it believes its program to be effective. In fact, the company filed a petition with the FDA asking the agency to ensure that generic makers have abuse-reduction programs similar to its effort.

"If you don't have a risk management program and you flood the market with generic oxycodone formulations, that seems to us like asking for trouble," said a Purdue spokesman. "It seems to us it should be an even playing field, and all companies should be held to the same standard."

Purdue is now seeking FDA approval for a new time-release painkiller, Palladone, but it has fought hard in court to retain the exclusivity of its major product. Endo won its first round of litigation in January when a judge in the Southern District of New York invalidated Purdue's patent because, the court found, the company misled federal patent regulators in obtaining it.

Purdue has filed an appeal in that case, which could take a year or more. Endo could decide to launch its generic product before then, but would face paying steep damages if the higher court overturned the ruling. Bill Newbould, a spokesman for Endo, said the company hasn't yet decided when it plans to launch its generic.

Teva has a patent litigation case pending in the same court and before the same judge for a different dosage. That trial hasn't yet begun, but Teva could choose to launch its product before the other appeal is settled. A spokesman for Teva said no such decision has yet been made.