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FDA: Guidance on development of abuse-deterrent opioid formulations
FDA issued a draft guidance last month to help the industry in the development of opioid drug formulations with abuse-deterrent properties, saying it considers development of these products a high public health priority.
The agency says the guidance provides recommendations for “the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, how those studies will be evaluated, and what labeling claims may be approved based on the results of those studies.”
POSSIBLE DETERRENTS
The announcement pointed to several possible deterrents to abuse including physical barriers to prevent chewing, crushing, cutting, grating, or grinding; chemical barriers that resist the extraction of the opioid using common solvents; agonist/antagonist combinations in which the antagonist would be active if the product is crushed or injected, for example; and aversion to create an unpleasant effect if the drug is manipulated prior to injection or a dose higher than directed is used.
In a telephone call with reporters, Douglas Throckmorton, MD, deputy director for regulatory programs in FDA’s Center for Drug Evaluation and Research, was repeatedly asked why drug manufacturers would be motivated to develop abuse-deterrent products if generic products don’t use the same standard.
Dr Throckmorton said FDA has received citizen petitions on the generic issue and will address them. However, he said, the hope is that if a product is labeled as having abuse-deterrent properties, that will make it more attractive for physicians to prescribe because it is safer.
He also said that the science of abuse deterrence is evolving and there are a number of things not well understood. If there are other mechanisms to achieve abuse deterrence, the agency would be interested in hearing about them, he asserted.
FDA is asking for comments on the guidance within the next 60 days, and it will announce a meeting on the issue in the future.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
