FDA Bars Generic Drugmakers From Producing Original OxyContin Formula
April 17, 2013

FDA Bars Generic Drugmakers From Producing Original OxyContin Formula

Lawrence LeBlond for redOrbit.com - Your Universe Online

Purdue Pharma´s OxyContin, a name-branded narcotic pain killer using the oxycodone formula, has long been a source of abuse for addicts. In a move to reduce that risk of abuse, Purdue in 2010 developed reformulated OxyContin tablets that would make it difficult for abusers to get a high off the drug.

But as the patent was set to expire this week on the original OxyContin formula, addicts everywhere could soon have a new avenue for getting their daily fix. In an ambitious effort to keep that from happening, the US Food and Drug Administration (FDA) set up a roadblock on that route.

In a report published today, the agency said it is blocking generic manufacturers from producing versions of the original crushable form of OxyContin, a decision that has been applauded by both politicians and law enforcement.

FDA spokeswoman Morgan Liscinsky said in a statement that “the FDA will not approve any generics to the original formulation of OxyContin,” and added that there are no FDA-approved generics of OxyContin on the market as of now.

The FDA also approved updated labeling for Purdue Pharma's reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets. The labeling indicates that the new formula has physical and chemical properties that would make it difficult for abusers to inject or snort the drug in order to get high.

The original OxyContin formula was first approved by the FDA in Dec. 1995. Ever since its debut, the product has been a source of abuse, with abusers looking for ways to defeat the extended-release benefits of the drug to get an instant high. But by bypassing the time-release mechanics, abusers were setting themselves up for serious adverse effects, including risk of overdose and death.

Purdue Pharma's updated reformulation in April 2010 was designed to make it difficult for abusers to manipulate the time-release effects of the drug. Shortly thereafter, in August 2010, Purdue stopped shipping original OxyContin to pharmacies.

Douglas Throckmorton, MD, deputy director for regulatory programs for the FDA´s Center for Drug Evaluation and Research, said: “The development of abuse-deterrent opioid analgesics is a public health priority for the FDA“¦ While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin.”

And the FDA has determined that the reformulated product is abuse-deterrent. OxyContin has been formulated to be extremely difficult to break, crush and dissolve, and forms a viscous hydrogel, which cannot be easily injected. However, while it is more difficult for the drug to be abused, the FDA noted that it is still possible.

Still, the benefits of the reformulation outweigh the risks of abuse. As with the old formula, the FDA found the risks far outweighed the benefits, which was a key reason it barred generic drug makers from using the original formula patent, which was set to expire today.

When any new drug formulation has abuse-deterrent properties, the FDA has the authority to require generics to have similar abuse-deterrent properties as well.

The FDA said it will update its evaluation of the effects of reformulated OxyContin when new data becomes available, as post-marketing assessments are still ongoing.

Purdue Pharma´s abuse-resistant formula for OxyContin will not expire until 2025.

Another manufacturer, Endo Pharmaceuticals, has also petitioned the FDA seeking claims that a newer version of its narcotic painkiller Opana, has abuse-resistant properties. If their claim proves successful, generic versions of its original formula would also be barred, according to a report from the NY Times Barry Meier.

Both Endo and Purdue have been pushing for tougher federal legislation requiring many opioids to be tamper-resistant, and have pushed for similar state laws. While these drug makers insist that their main goal is to protect the public´s health, some note that these companies are pushing for reformulated versions of their products only to avoid losing patent protection.

And while the move is seen as a step in the right direction for the fight against prescription drug abuse, some also worry that the FDA´s decision to ban generic versions of OxyContin will result in higher drug prices for Purdue Pharma's painkiller.

In 2010, before the reformulated version was produced, OxyContin cost about $6.00 for a 40 mg tablet. Since the new version came out, the price has risen to about $6.80 for the same dosage.

In 1995 when the FDA approved the original formula for OxyContin, Purdue maintained that the drug´s time-release formulation would make it difficult to be abused. “That contention proved disastrously wrong,” wrote the Times´ Meier.