Four pharmaceuticals have begun patient testing on the new drug, and one company, Zogenix in San Diego, Calif., says it plan to apply to the FDA to market the drug in 2013 under the name Zohydro.
Prescription drug abuse treatment in America has climbed 403 percent in the past decade, and both addiction experts and drug control advocates are convinced that a mega-dose of hydrocodone, that same ingredient found in Vicodin and OxyContin, will just make things worse.
Ten Times Stronger Than Vicodin
Hydrocodone has been a popular painkiller and abusive drug in the U.S. for decades. As part of the opium family, drugs containing hydrocodone include morphine, heroin and methadone.
Both Vicodin and OxyContin contain opiates as a primary ingredient, but Vicodin is mixed with acetaminophen.
According to The Daily News, however, this new painkiller isn't mixed with anything. If approved, it would be the first time in U.S. history that patients could legally buy pure hydrocodone, and the resulting drug would have a potency ten times that of Vicodin.
If approved, it would mark the first time patients could legally buy pure hydrocodone.
'This could be the next Oxycontin.'
As Zogenix prepares to launch Zohydro in 2013, however, drug control advocates and addiction experts are less concerned about Vicodin's track record than they are about a more infamous drug: OxyContin.
When OxyContin was first introduced in 1995, it was supposed to operate as a time-release drug releasing small doses of the painkiller over many hours. Addicts, however, soon discovered that the drug could be crushed up instead for an instantaneous and far more potent effect.
When OxyContin manufacturers changed the formula to make it more tamper-resistant, abusers turned to generic oxycodone instead.
Now, drug control advocates like April Rovero are pushing to have the drug re-evaluated, worried that addicts will turn to products like Zohydro to satisfy their cravings.
I have a big concern that this could be the next OxyContin, Rovero, president of the National Coalition Against Prescription Drug Abuse, told AP. We just don't need this on the market.
Oxycodone is currently the most-abused drug in the U.S., with the hydrocodone found in Vicadin a close second.
The Drug Enforcement Administration (DEA) also notes that emergency room visits for hydrocodone abuse have spiked since 2000, going from 19,221 in a year to 86,258 in 2009.
Companies Argue New Painkiller Safer, More Effective
Egalet, a Denmark-based pharmaceutical company, is one of the manufacturers working on a pure hydrocodone pill, and chief executive Karsten Lindhardt defended the new drugs as a better way for doctors to help patients with very severe, very legitimate pain.
Sometimes you circulate a patient between various opioids, and some may have a better effect than others, Lindhardt told CBS.
Zogenix chief executive Roger Hawley, meanwhile, assured investors in New York last week that Zohydro would actually be safer than Vicodin because acetaminophen, the missing mixer, can be dangerous to the liver.
Drug companies also argue that the new painkiller will be more closely regulation than products like Vicodin and thus be safer for the patients.
Prescriptions for weaker, acetaminophen-mixed painkillers can be refilled up to five times without a doctor's visit. By law, patients using pure hydrocodone would have to go to a doctor each time they needed more pills.
'You've got a person on your product for life.'
Drug control advocates like Physicians for Responsible Opioid Prescribing, however, remain unconvinced, and opiates are dangerous enough that their protests could have a serious effect on the FDA's decision.
Opiates are exceptional pain blockers, but also release an accompanying feeling of euphoria that causes many to use the drug recreationally, creating a potent dependence over time.
Withdrawal symptoms are intense and can include tremors, extreme pain, diarrhea, vomiting and akathisia (the inability to remain still), according to The National Insitute on Drug Abuse.
Other side effects include priapism (a persistent and usually painful erection), tachycardia (dangerously rapid heart rate), and psychological symptoms like intense cravings, panic attacks, insomnia and dysphoria, characterized by intense feelings of depression and a heightened risk of suicide.
Nor are addicts looking for a fix the only issue. Addiction experts warn that many patients treating legitimate pain could end up becoming addicted to the new painkiller, along with the thousands consuming and abusing them illegally.
The U.S. Centers for Disease Control and Prevention (CDC) said last month that prescription painkillers caused 15,000 deaths in 2008, more than triple the 4,000 deaths in 1999.
Because both chronic pain and drug abuse can be a lifelong condition, PROP is worried that pharmaceutical companies are more concerned about making a quick billion than about the thousands who are or could become addicted.
You've got a person on your product for life, and a doctor's got a patient who's never going to miss an appointment, because if they did and they didn't get their prescription, they would feel very sick, PROP president Andrew Kolodny told CBS News Stakk.
It's like the Wild West, Peter Jackson added in an interview with The Detroit Free Press. Jackson is the co-founder of Advocates for the Reform of Prescription Opioids.
The whole supply-side system is set up to perpetuate this massive unloading of opioid narcotics on the American public.
Drug Companies Continue Testing
Egalet, Zogenix, and fellow companies Purdue Pharma and Cephalon all plan to go ahead with the new painkiller.
Purdue Pharma and Cephalon are conducting late-stage trials, and Egalet has finished preliminary testing.
According to the International Narcotics Contorl Board, the U.S. consumes roughly 99 percent of the world's hydrocodone. It consumes 83 percent of its oxycodone.