The manufacturer of OxyContin said Wednesday that it had successfully tested a tamper-resistant form of another powerful painkiller, hydrocodone — an announcement that could upend this month’s release of the controversial drug Zohydro, which has faced widespread criticism in part for its lack of such safety measures.
Connecticut-based Purdue Pharma said it will soon seek approval from the Food and Drug Administration for its version of an extended-release hydrocodone drug, which it says is less prone to abuse because its design makes it hard for users to crush the pill and inject or snort its contents.
“This is another step forward in our efforts to develop therapeutic options for use by chronic pain patients that are designed to be unattractive to drug seekers,” Gary L. Stiles, the company’s senior vice president of research and development, said in a statement.
The news comes amid an ongoing uproar over the recent release of Zohydro, the first prescription narcotic comprising a pure dose of hydrocodone, the main ingredient in the painkiller Vicodin.
Hydrocodone, part of a group of drugs known as opiates that includes morphine and heroin, has proven effective at treating pain from surgeries, injuries and other ailments but also has played a central role in the nation’s ongoing prescription painkiller addiction epidemic.
Before Zohydro, hydrocodone was available only in combinations that included non-addictive pain medications, such as acetaminophen. The drug’s California manufacturer, Zogenix, says the pure formulation allows for long-term use without the risk of liver damage and would offer a much-needed treatment for chronic pain sufferers.
But critics have warned that such a formulation also makes the drug easier to abuse. In addition, they argue that Zohydro’s lack of tamper-resistant features, coupled with its potency — the strongest version includes 10 times the amount of hydrocodone in many Vicodin pills — is a recipe for disaster.
Overdose deaths in the United States have skyrocketed since 2000, largely because of the prevalence of prescription painkillers, according to the Centers for Disease Control and Prevention. About 15,000 Americans die each year from prescription drug overdoses, the agency estimates, and millions more misuse the drugs for nonmedical purposes.
The FDA came under fire last October after its decision to approve Zohydro, despite an 11 to 2 recommendation to the contrary by its own outside advisory panel. The agency has continued to face pressure to reconsider its decision from law enforcement officials, addiction experts and lawmakers from both parties.
In recent days, Senate Democrats Joe Manchin III (W.Va.) and Charles E. Schumer (N.Y.) have urged the Obama administration to roll back the FDA’s decision. Three Republican senators — Mitch McConnell (Kentucky), Tom Coburn (Oklahoma) and Lamar Alexander (Tennessee) — recently demanded to know what safeguards the FDA had put in place with Zohydro, warning that its approval “could worsen the drug abuse epidemic in our country.”
Last fall, more than two dozen state attorneys general wrote to FDA Commissioner Margaret A. Hamburg, saying that law enforcement officers, substance abuse workers and others are “just now beginning to stem the tide of prescription drug addiction. We do not want to see their work undone.”
On the front lines of the fight against prescription drug abuse, people such as Bill Mark have been bracing for the arrival of Zohydro. After the FDA approved the drug last fall, the director of the Northern Kentucky Drug Strike Force worried that the arrival of another powerful narcotic in his drug-ravaged corner of the country would bring another round of overdoses and deaths.
“It’s just a matter of time. It’s not if, it’s when,” Mark said, referring to Zohydro as “a prescription drug abuser’s dream.”
Wednesday’s announcement by Purdue could alter that landscape. If the company’s harder-to-abuse hydrocodone drug wins approval — in 2010, it introduced a tamper-resistant version of OxyContin — doctors might be more willing to prescribe it than a formulation without such safeguards. In addition, the FDA could decide to halt sales of Zohydro if regulators are convinced a safer version exists.
“A non-crushable, abuse-resistant opioid formulation of hydrocodone certainly would be preferable” to Zohydro, said Michael Carome, director of medical research at the consumer watchdog group Public Citizen. “We believe it would be in the best interests from a public health standpoint if Zogenix stopped marketing Zohydro until such a formulation is available.”
FDA spokeswoman Morgan Liscinsky said Wednesday that the agency could not comment on the status of product applications, but that it considers the development of opioid drugs with abuse-deterrent properties “to be a public health priority.”
The stock price of Zogenix fell more than 20 percent in the wake of Wednesday’s announcement. For its part, the company said in a statement that “deterring opioid abuse requires solutions that go well beyond abuse deterrent formulations” and include educating doctors and patients alike. Still, the company has said it is continuing to work on its own tamper-resistant form of Zohydro, with a goal of getting it to market by 2016.