December 27, 2011
New Painkiller Is 10 Times Stronger Than Vicodin
Drug companies are working to develop a prescription painkiller much more powerful than Vicodin, worrying addiction experts that it could lead to a new wave of drug abuse.
With prescription painkiller abuse treatment climbing 430 percent over the past decade, addiction experts and drug control advocates are concerned that a new mega-dose of hydrocodone, the powerful ingredient found in the drugs Vicodin and OxyContin, will make things worse.The new painkiller has up to 10 times the amount of hydrocodone found in the other drugs, with four pharmaceuticals beginning patient testing. One of those companies -- Zogenix of San Diego -- says it plans to apply next year to begin marketing its drug in 2013, Zohydro.
If approved, it would mark the first time patients could legally buy pure hydrocodone.
Hydrocodone belongs to a family of drugs known as opiates because they are chemically similar to opium. They include morphine, heroin, oxycodone, codeine, and methadone. Health experts are especially concerned about Zohydro, a timed-release drug meant for moderate to severe pain.
“I have a big concern that this could be the next OxyContin,” April Rovero, president of the National Coalition Against Prescription Drug Abuse, told the Associated Press (AP). “We just don´t need this on the market.”
OxyContin, introduced in 1995, was designed to manage pain with a formula that dripped a single dose of oxycodone over many hours. But abusers quickly found they could defeat the timed-release effect by crushing the pills up. Purdue Pharma, the maker of OxyContin, changed the formula to make it more tamper-resistant, but addicts have moved onto generic oxycodone and other drugs.
Oxycodone is now the most-abused drug in the US, with hydrocodone second, according to data from the Drug Enforcement Administration (DEA). DEA data also shows emergency room visits related to hydrocodone spiked from 19,221 in 2000 to 86,258 in 2009.
Opiates block pain but also unleash intense feelings of well-being and can create physical dependence. The withdrawal symptoms are also intense, with users complaining of cramps, diarrhea, muddled thinking, nausea and vomiting. After a while, opiates stop working, forcing users to take stronger doses or to try slightly different chemicals.
“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,” Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing told CBS News Stakk. “It´s a terrific business model, and that´s what these companies want to get in on,” he added.
Pharmaceuticals say the new drugs give doctors another tool to help patients in legitimate pain.
“Sometimes you circulate a patient between various opioids, and some may have a better effect than others,” Karsten Lindhardt, chief executive of Denmark-based Egalet, which is testing its own pure hydrocodone product, told CBS.
Zogenix has already completed three rounds of patient testing, and last week announced it held a final meeting with FDA officials to talk about its upcoming drug application.
The companies Perdue Pharma, Cephalon, and Egalet are also developing their own versions of the super-powered painkiller.
Purdue Pharma and Cephalon, a Frazer, Pa.-based unit of Israel-based Teva Pharmaceuticals, are conducting late-stage trials of hydrocodone drugs, according to documents filed with federal regulators. In May, Purdue Pharma received a patent applying extended-release technology to hydrocodone.
Egalet has finished the most preliminary stages of safety testing and could have a product on the market as early as 2015 but wants to see how the other companies fare with the FDA before deciding whether to move forward, Lindhardt said.
Critics are concerned because they fear a new class of or powerful narcotics will lead to more murders, pharmacy robberies, and millions of dollars lost by hospitals to treat overdose victims. Thousands of legitimate pain patients are becoming addicted to painkillers, and thousands more are abusing them illegally.
The US Centers for Disease Control and Prevention (CDC) said last month that prescription painkillers caused 15,000 US deaths in 2008, more than triple the 4,000 deaths in 1999.
The US consumes 99 percent of the world´s hydrocodone and 83 percent of its oxycodone, according to a 2008 study by the International Narcotics Control Board.
On the Net:
- National Coalition Against Prescription Drug Abuse
- Purdue Pharma
- Physicians for Responsible Opioid Prescribing
- Teva Pharmaceuticals
- International Narcotics Control Board