It has not even hit the market yet, and already a powerful new painkiller is arousing debate among doctors specializing in pain management.
The drug is a new formulation that would allow doctors for the first time ever to prescribe pure hydrocodone to their patients. According to the National Institutes of Health, hydrocodone is already a component of 404 separate branded drugs; in each case, it is mixed with some other medication. Vicodin, a well-known example, is a combination of hyrocodone and acetaminophen, which is the active ingredient in Tylenol.
Four companies are each working on their own versions of the drug, and the earliest of these could hit the market in 2013 if approved by the U.S. Food and Drug Administration, according to Associated Press reports.
But should such a product even be available, particularly in light of the country's growing battle with prescription painkiller addiction? At the center of the debate is the question of whether the possible benefits of such a pill, which would potentially carry many times the amount of hydrocodone than the amount in current combination medicines, would outweigh the risks linked to the addictive potential.
"Oh, it is very addictive," said Dr.Lloyd Saberski, medical director of the New Haven, Ct.-based Advanced Diagnostic Pain Treatment Centers. "But so are oxycodone, Dilaudid, Demerol and morphine. Why should this product be discriminated upon more so than the other products?"
Saberski added that existing FDA regulations would protect the public from the misuse of this new drug.
"If the controls in place are failing, then we need to look at how to improve them for all the opioid class medications," he said. "Curtailing the availability of opioid would not help us provide medical care."
Other pain management physicians say adding pure hydrocodone to the mix of addictive prescription pain drugs already available will only make the country's painkiller abuse problem worse. One of these physicians is Dr. Joel Saper, founder and director of the Michigan Head Pain and Neurological Institute in Ann Arbor.
"I don't think we need another opioid," Saper said. "We need better education, more sanity, and we need to stop treating benign pain with more narcotics."
Saper said that while it would make sense for pain management doctors to be able to prescribe hydrocodone as a painkiller without the acetaminophen in Vicodin - which can cause acute liver toxicity if too much is taken - there are currently other approaches available to doctors that allow them to treat pain with existing drugs.
Saper said that adding another drug to the mix would be a mistake in light of the country's prescription drug abuse problem.
"Drug deaths from [opiates] exceed both auto and gun deaths," he said. "So do I think we need another narcotic marketed and hyped?
"We shouldn't be putting more bullets onto the street."
Additionally, Dr. Joshua Prager, director of the Center for the Rehabilitation Pain Syndromes at UCLA Medical Plaza, said so many opiate drugs currently exist that another may not be necessary.
"The question is, how many arrows do you need in the quiver?" he said. "I can name so many opiates that can do the job. They're all pretty similar, so what's the point here?
"I'm a very strong advocate of pain relief and using opiates," he continued. "But I don't see where this gives anyone anything different than what's already on the market."
Another issue at the center of the debate is the question of who should be allowed to prescribe powerful pain medications in the first place. These medicines are currently used by many doctors who have no background in pain management.
"What is urgently needed is FDA approval of effective and safe analgesics (e.g. hydrocodone) but also a national policy to restrict opioid prescriptions to legitimate and trained practitioners [and] put the pill mills out of business … and have a patient monitoring system to assure safe prescription and use," said Dr. Elliot Krane, director of pediatric pain management at Lucile Packard Children's Hospital in San Francisco. "What is not needed are Draconian measures that deprive patients of effective opioid therapy or demonize chronic pain patients who are dependent on opioids for comfort and to function."
What do you think? Should the FDA approve yet another opioid painkiller?