NEW YORK (AP) â€" Drug companies are operative to rise a pure, some-more absolute chronicle of a nation's second most-abused medicine, that has obsession experts disturbed that it could coax a new call of abuse.
The new pills enclose a rarely addictive painkiller hydrocodone, make-up adult to 10 times a volume of a drug as existent drugs such as Vicodin. Four companies have begun studious testing, and one of them â€" Zogenix of San Diego â€" skeleton to request early subsequent year to start selling a product, Zohydro.
If approved, it would symbol a initial time patients could legally buy pristine hydrocodone. Existing products mix a drug with nonaddictive painkillers such as acetaminophen.
Critics contend they are generally disturbed about Zohydro, a timed-release drug meant for handling assuage to serious pain, given abusers could vanquish it to recover an intense, evident high.
"I have a large regard that this could be a subsequent OxyContin," pronounced Apr Rovero, boss of a National Coalition Against Prescription Drug Abuse. "We usually don't need this on a market."
OxyContin, introduced in 1995 by Purdue Pharma of Stamford, Conn., was designed to conduct pain with a regulation that dribbled one sip of oxycodone over many hours.
Abusers fast detected they could improved a timed-release underline by abrasive a pills. Purdue Pharma altered a regulation to make OxyContin some-more tamper-resistant, though addicts have changed onto general oxycodone and other drugs that do not have a timed-release feature.
Oxycodone is now a most-abused medicine in a United States, with hydrocodone second, according to a Drug Enforcement Administration's annual count of drug seizures sent to military drug labs for analysis.
The latest drug tests come as some-more curative companies are removing into a $10 billion-a-year authorised marketplace for absolute â€" and addictive â€" soporific narcotics.
"It's like a furious west," pronounced Peter Jackson, co-founder of Advocates for a Reform of Prescription Opioids. "The whole supply-side complement is set adult to continue this large unloading of opioid narcotics on a American public."
The curative firms contend a new hydrocodone drugs give doctors another apparatus to try on patients in legitimate pain, partial of a consistent hunt for improved painkillers to provide a aging U.S. population.
"Sometimes we disseminate a studious between several opioids, and some might have a improved outcome than others," pronounced Karsten Lindhardt, arch executive of Denmark-based Egalet, that is contrast a possess pristine hydrocodone product.
The companies contend a pristine hydrocodone tablet would equivocate liver problems associated to high doses of acetaminophen, an part in products like Vicodin. They also contend patients will be some-more closely supervised because, by law, they will have to lapse to their doctors any time they need some-more pills. Prescriptions for a weaker, hydrocodone-acetaminophen products now on a marketplace can be refilled adult to 5 times.
Zogenix has finished 3 rounds of studious testing, and final week it announced it had hold a final assembly with Food and Drug Administration officials to speak about a arriving drug application. It skeleton to record a focus in early 2012 and have Zohydro on a marketplace by early 2013.
Purdue Pharma and Cephalon, a Frazer, Pa.-based section of Israel-based Teva Pharmaceuticals, are conducting late-stage trials of their possess hydrocodone drugs, according to papers filed with sovereign regulators. In May, Purdue Pharma perceived a obvious requesting extended-release record to hydrocodone. Neither association would criticism on a plans.
Meanwhile, Egalet has finished a many rough stages of contrast directed during final a simple reserve of a drug. The organisation could have a product on a marketplace as early as 2015 though wants to see how a other companies transport with a FDA before determining either to pierce forward, Lindhardt said.
Critics contend they are uneasy given of a dim side that has accompanied a bang in sales of analgesic painkillers: Murders, pharmacy robberies and millions of dollars mislaid by hospitals that contingency provide overdose victims.
Thousands of legitimate pain patients are apropos dependant to absolute medication painkillers, they say, in further to a thousands some-more who abuse a drugs.
Prescription painkillers led to a deaths of roughly 15,000 people in 2008, some-more than triple a 4,000 deaths in 1999, a Centers for Disease Control and Prevention reported final month.
Emergency room visits associated to hydrocodone abuse have shot from 19,221 in 2000 to 86,258 in 2009, according to information gathered by a Drug Enforcement Administration. In Florida alone, hydrocodone caused 910 deaths and contributed to 1,803 others between 2003 and 2007.
Hydrocodone belongs to family of drugs famous as opiates or opioids given they are chemically identical to opium. They embody morphine, heroin, oxycodone, codeine, methadone and hydromorphone.
Opiates retard pain though also unleash heated feelings of contentment and can emanate earthy dependence. The withdrawal symptoms are also intense, with users angry of cramps, diarrhea, perplexed thinking, revulsion and vomiting.
After a while, opiates stop working, forcing users to take stronger doses or to try somewhat opposite chemicals.
"You've got a chairman on your product for life, and a doctor's got a studious who's never going to skip an appointment, given if they did and they didn't get their prescription, they would feel really sick," pronounced Andrew Kolodny, boss of Physicians for Responsible Opioid Prescribing. "It's a superb business model, and that's what these companies wish to get in on."
Under vigour from a government, Purdue Pharma final year debuted a new OxyContin tablet regulation that "squishes" instead of exploding when someone tries to vanquish it.
But Zogenix, whose drug is time-released though crushable, says there is not adequate justification to uncover that such tamper-resistant reformulations frustrate abuse.
"Provided sufficient effort, all formulations now accessible can be overcome," Zogenix pronounced in a created response to questions by The Associated Press.
At a discussion for investors New York on Nov. 29, Zogenix arch executive Roger Hawley pronounced a FDA was not pressuring Zogenix to put an abuse halt in Zohydro.
"We would positively cruise after rising an abuse-deterrent form, though right now we trust a priority of safer hydrocodone â€" that is, though acetaminophen â€" is a pivotal priority for a FDA," Hawley said.
FDA mouthpiece Erica Jefferson pronounced a group would not criticism on a discussions with drug companies, citing a need to strengthen trade secrets.
Drug control advocates contend they're disturbed a U.S. supervision is too messy about determining addictive pain medications. The United States consumes 99 percent of a world's hydrocodone and 83 percent of a oxycodone, according to a 2008 investigate by a International Narcotics Control Board.
One 41-year-old loophole in sold has fed a stream problem with hydrocodone abuse, critics say. The sovereign Controlled Substances Act, upheld in 1970, puts fewer controls on multiple pills containing hydrocodone and another painkiller than it does on a homogeneous oxycodone products.
A Vicodin medication can be refilled 5 times, for example, while a Percocet medication can usually be filled once.
The Drug Enforcement Administration and Food and Drug Administration have been study either to tie this loophole given 1999 though have done no decision. Congress is now deliberation a check that would force a agencies to tie a controls.
"This is a problem that is essentially an oversupply problem," pronounced Jackson, a drug-control advocate. "The FDA has kind of non-stop a floodgates, and they exclude to commend a mistakes done in a past."
Pure hydrocodone falls into a stricter drug-control difficulty than hydrocodone-acetaminophen medications, definition patients would have to go to their doctors for a new medication any time they indispensable some-more pills. But Jackson pronounced that's no pledge opposite abuse, observant that dozens of unethical doctors have been held churning out prescriptions in supposed "pill mills."
The Drug Enforcement Administration, that enforces controls on medicines along with a FDA, pronounced it could not criticism on drugs that have not nonetheless been authorized for sale.
However, Zogenix has concurred a abuse emanate could turn a liability.
"Illicit use and abuse of hydrocodone is good documented," it pronounced in a filing with a Securities and Exchange Commission in September. "Thus, a regulatory capitulation routine and a selling of Zohydro might beget open debate that might adversely impact regulatory capitulation and marketplace acceptance of Zohydro."
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