FDA: Draft guidance issued on abuse-deterrent opioids
January 10, 2013 in Medications
The U.S. Food and Drug Administration has issued a draft guidance document to assist the pharmaceutical industry in developing new formulations of opioid drugs with abuse-deterrent properties.
(HealthDay)—The U.S. Food and Drug Administration has issued a draft guidance document to assist the pharmaceutical industry in developing new formulations of opioid drugs with abuse-deterrent properties.
The document entitled "Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling," details the FDA's current thinking about the studies that should be done to demonstrate abuse-deterrent properties in a given formulation, how those studies will be evaluated by the FDA, and what labeling claims may be approved based on the study results.
This draft guidance fulfills mandates under the Food and Drug Administration Safety and Innovation Act and the Office of National Drug Control Policy's Prescription Drug Abuse Prevention Plan, according to information from the FDA.
"The FDA is extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation," FDA Commissioner Margaret A. Hamburg, M.D., said in a statement. "This draft guidance is an important part of a larger effort by [the] FDA aimed at preventing prescription drug abuse and misuse."
More information: More Information
Copyright © 2012 HealthDay. All rights reserved.
-
Teach prescribers about dangers of long-acting pain meds: FDA
Jul 09, 2012 |
not rated yet |
0
-
FDA wants drug companies to look at potential for abuse
Jan 30, 2010 |
not rated yet |
0
-
Many who first misuse prescription pills get them from friends, family: report
Apr 25, 2012 |
not rated yet |
0
-
New FDA program adds to tools to curb opiod abuse in United States
Aug 01, 2012 |
not rated yet |
0
-
FDA Web site explains agency operations to public
Jan 12, 2010 |
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 villous adenoma in colon, if there are no villi there
5 hours ago
-
How can there be a term called "intestinal metaplasia" of stomach
May 21, 2013
-
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
- More from Physics Forums - Medical Sciences
More news stories
Study finds new pneumococcal vaccine appears to be as safe as previously used vaccine
The new 13-valent pneumococcal conjugate vaccine (PCV13) appears to be as safe as the previous version used prior to 2010, the 7-valent pneumococcal conjugate vaccine (PCV7), according to a Kaiser Permanente study published ...
Medications
1 hour ago |
not rated yet |
0
Succesful results in developing oral vaccine against diarrhea
The University of Gothenburg Vaccine Research Institute (GUVAX) announces successful results in a placebo controlled phase I study of an oral, inactivated Escherichia coli diarrhea vaccine.
Medications
4 hours ago |
not rated yet |
0
New sleeping pill poised to hit US markets
An experimental sleeping pill from US drug company Merck is effective at helping people fall and stay asleep, according to reviewers at the US Food and Drug Administration, which could soon approve the new drug.
Medications
18 hours ago |
4.2 / 5 (5) |
0
Global recommendations on child medicine
Transparent information on the evidence supporting global recommendations on paediatric medicines should be easily accessible in order to help policy makers decides on what drugs to include in their national drug lists, according ...
Medications
19 hours ago |
not rated yet |
0
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
May 21, 2013 |
not rated yet |
0
Scientists uncover molecular roots of cocaine addiction in the brain
Researchers at Johns Hopkins have unraveled the molecular foundations of cocaine's effects on the brain, and identified a compound that blocks cravings for the drug in cocaine-addicted mice. The compound, already proven safe ...
Taming suspect gene reverses schizophrenia-like abnormalities in mice
Scientists have reversed behavioral and brain abnormalities in adult mice that resemble some features of schizophrenia by restoring normal expression to a suspect gene that is over-expressed in humans with ...
Costs to treat stroke in America may double by 2030
Costs to treat stroke are projected to more than double and the number of people having strokes may increase 20 percent by 2030, according to the American Heart Association/American Stroke Association.
Acne treatment: Natural substance-based formula is more effective than artificial compounds
University of Granada scientists have patented a new treatment for acne that is based on completely natural substances and is much more effective than artificial formulas because it does not create resistance ...
A molecular explanation for age-related fertility decline in women
(Medical Xpress)—Scientists supported by the National Institutes of Health have a new theory as to why a woman's fertility declines after her mid-30s. They also suggest an approach that might help slow ...
Addiction to unhealthy foods could help explain the global obesity epidemic
Research presented today shows that high-fructose corn syrup can cause behavioural reactions in rats similar to those produced by drugs of abuse such as cocaine. These results, presented by addiction expert Francesco Leri, ...
