US panel opposes pure hydrocodone painkiller
December 9, 2012 by Matthew Perrone in Medications
(AP)—U.S. government health experts overwhelmingly voted against a stronger version of hydrocodone on Friday, questioning the need for a new form of one of most widely abused prescription painkillers.
The Food and Drug Administration's panel of pain specialists voted 11-2 with one abstention against Zohydro for moderate to severe chronic pain. The drug was developed as a long-acting pain reliever by San Diego-based Zogenix Inc.
The FDA is not required to follow the group's recommendation, though it often does so. It is scheduled to make its decision on the drug by March 1.
The panelists acknowledged that the pill would likely reduce pain, but worried it would exacerbate the U.S. epidemic of prescription painkiller abuse.
"I think the sponsor fulfilled the expectations of FDA, however I think the entire class is problematic in terms of abuse and safety issues," said Professor James Ware of the Harvard School of Public Health.
If approved, Zohydro would be the first pure hydrocodone medication available in the U.S. Currently available products combine the drug with lower-grade painkillers such as acetaminophen.
Hydrocodone is prescribed to treat pain from injuries, surgery, arthritis, migraines and a variety of other ailments.
Hydrocodone-containing pills consistently rank as the first or second most-abused medicines in the U.S., according to the Drug Enforcement Administration.
The drug belongs to a family of medicines known as opiates or opioids because they are chemically similar to opium. They include morphine, heroin, oxycodone, codeine, methadone and hydromorphone.
Opiates block pain but also unleash intense feelings of well-being and can create physical dependence. Several panelists said the risks of fatal overdose with opioids swayed their vote against Zohydro.
In 2011, the U.S. Centers for Disease Control estimated 14,800 deaths were related to opioids.
Zogenix has touted the benefits of its long-lasting pill, which only needs to be taken once every 12 hours, compared with every four to six hours for combination drugs like Vicodin. The company also notes that patients taking pure hydrocodone would not be at risk for acetaminophen-related liver side effects.
In recent years the FDA has begun prodding drugmakers to develop more sophisticated pain relievers that are harder to abuse, but such measures are not a requirement.
Shares of San Diego-based Zogenix were halted ahead of the meeting and last traded at $2.36.
Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
-
New powerful painkiller has abuse experts worried
Dec 26, 2011 |
not rated yet |
0
-
Senator warns FDA on danger of newest painkillers
Jan 08, 2012 |
not rated yet |
0
-
FDA cracks down on hydrocone products
Sep 29, 2007 |
not rated yet |
0
-
FDA orders lower doses in prescription painkillers
Jan 13, 2011 |
not rated yet |
0
-
FDA: 'limited' benefit with tamper-proof OxyContin
Sep 22, 2009 |
not rated yet |
0
-
Motion perception revisited: High Phi effect challenges established motion perception assumptions
Apr 23, 2013 |
3 / 5 (2) |
2
-
Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update)
Apr 02, 2013 |
4.5 / 5 (11) |
5
-
The visual system as economist: Neural resource allocation in visual adaptation
Mar 30, 2013 |
5 / 5 (2) |
9
-
Separate lives: Neuronal and organismal lifespans decoupled
Mar 27, 2013 |
4.9 / 5 (8) |
0
-
Sizing things up: The evolutionary neurobiology of scale invariance
Feb 28, 2013 |
4.8 / 5 (10) |
14
-
How can there be a term called "intestinal metaplasia" of stomach
8 hours ago
-
Pressure-volume curve: Elastic Recoil Pressure don't make sense
May 18, 2013
-
If you became brain-dead, would you want them to pull the plug?
May 17, 2013
-
MRI bill question
May 15, 2013
-
Ratio of Hydrogen of Oxygen in Dessicated Animal Protein
May 13, 2013
-
Alcohol and acetaminophen
May 13, 2013
- More from Physics Forums - Medical Sciences
More news stories
Analgesics prescribed more heavily to women than to men, study finds
Regardless of pain, social class or age, a woman is more likely to be prescribed pain-relieving drugs. A study published in Gaceta Sanitaria (Spanish health scientific journal) affirms that this phenomenon is inf ...
Medications
5 hours ago |
not rated yet |
0
Breakup of physician, drug company relationship could improve health care, cut cost
A new report suggests that improved health care and significant reductions in drug costs might be attained by breaking up the age-old relationship between physicians and drug company representatives who promote the newest, ...
Medications
May 20, 2013 |
5 / 5 (1) |
0
FDA has safety concerns on Merck insomnia drug
Federal health regulators say an experimental insomnia drug from Merck can help patients fall asleep, but it also carries worrisome side effects, including daytime drowsiness and suicidal thinking.
Medications
May 20, 2013 |
not rated yet |
0
US adviser on board of firm that sold anthrax drug
(AP)—Former Navy Secretary Richard J. Danzig, who has served as a bio-warfare adviser to the president, the Pentagon, and the Department of Homeland Security, urged the government to stockpile an anti-anthrax drug while ...
Medications
May 20, 2013 |
5 / 5 (1) |
0
Acne pill benefits outweigh blood clot risk: EU agency
Europe's medicines watchdog said Friday the benefits of acne drug Diane-35, also widely used as a contraceptive, outweigh the risk of developing blood clots in the veins—when correctly prescribed.
Medications
May 17, 2013 |
not rated yet |
0
Drugs found to both prevent and treat Alzheimer's disease in mice
Researchers at USC have found that a class of pharmaceuticals can both prevent and treat Alzheimer's Disease in mice.
Decisions to forgo life support may depend heavily on the ICU where patients are treated
The decision to limit life support in patients in the intensive care unit (ICU) appears to be significantly influenced by physician practices and/or the culture of the hospital, suggests new findings from researchers at the ...
Better behavior after tonsil/adenoid surgery for kids with sleep breathing trouble?
Children with obstructive sleep apnea who had a common surgery to remove their tonsils and adenoids showed notable improvements in behavior, quality of life and other symptoms compared to those treated with "watchful waiting" ...
If you can remember it, you can remember it wrong
(Medical Xpress)—Native peoples in regions where cameras are uncommon sometimes react with caution when their picture is taken. The fear that something must have been stolen from them to create the photo ...
B vitamins could delay dementia
(Medical Xpress)—Despite spending billions of dollars on research and development, drug companies have been unable to come up with effective treatments for dementia and Alzheimer's Disease (AD). Now, A. ...
Insight into the dazzling impact of insulin in cells
Australian scientists have charted the path of insulin action in cells in precise detail like never before. This provides a comprehensive blueprint for understanding what goes wrong in diabetes.