The Abuse ‐​Deterrent Folly

Jeffrey A. SingerOn September 11 a  Food and Drug Administration Advisory Committeerecommended rejecting Purdue Pharma ’s request to add to the label of the abuse‐​deterrent formulation (ADF) of its drug OxyContin the claim that it reduces the incidence of non‐​medical use and overdose from opioids.In the early part of this century law enforcement officialsreported that many non ‐​medical users of the diverted prescription drug OxyContin, a concentrated, slow‐​release formulation of oxycodone, would crush the pills and snort them, or dissolve them in liquid and inject them. In 2010, as its patent for OxyContin was about to expire and cheaper generic competitors wer e waiting in the wings, Purdue Pharma received FDA approval to release its reformulated ADF OxyContin. This reformulation made the pills uncrushable and insoluble in liquid. The reformulation approval meant Purdue Pharma could extend its patent—and its monopoly—over the production and sale of O xyContin. Extending drug patents by reformulating drugs in a meaningful way—a process known as “evergreening”—is a common practice in the pharmaceutical industry.In anironic twist, the pharmaceutical company that was, by then,  the opiophobia‐​drivenscapegoat for the overdose crisis sought to profit from  further stoking opiophobia. The FDA didn’t just approve the ADF of OxyContin–itencou...
Source: Cato-at-liberty - Category: American Health Authors: Source Type: blogs

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AbstractOpioid overdose accounted for more than 47,000 deaths in the United States in 2018. The risk of new persistent opioid use following breast cancer surgery is significant, with up to 10% of patients continuing to fill opioid prescriptions one year after surgery. Over prescription of opioids is far too common. A recent study suggested that up to 80% of patients receiving a prescription for opioids post-operatively do not need them (either do not fill the prescription or do not use the medication). In order to address this important issue, The American Society of Breast Surgeons empaneled an inter-disciplinary committe...
Source: Annals of Surgical Oncology - Category: Cancer & Oncology Source Type: research
CONCLUSIONS: To our knowledge, this is the first example of a statewide collaboration among diverse health professional education programs to create a single, standard curriculum. This collaborative process and the nonproprietary Arizona Pain and Addiction Curriculum may serve as a useful template for other states to enhance pain and addiction education. PMID: 32962529 [PubMed - as supplied by publisher]
Source: Public Health Reports - Category: International Medicine & Public Health Tags: Public Health Rep Source Type: research
More than 25 million Americans suffer from daily chronic pain, a highly debilitating medical condition that is complex and difficult to manage. In recent decades, there has been an overreliance on the prescription of opioids for chronic pain, contributing to a significant and alarming epidemic of opioid overdose deaths and addiction. Innovative scientific solutions to develop non-opioid, non-addictive alternative treatment options are thus urgently needed. One of the goals of the Helping to End Addiction Long-term (HEAL) Initiative is to accelerate the discovery and preclinical development of new medications and devices t...
Source: Videocast - All Events - Category: General Medicine Tags: Upcoming Events Source Type: video
More than 25 million Americans suffer from daily chronic pain, a highly debilitating medical condition that is complex and difficult to manage. In recent decades, there has been an overreliance on the prescription of opioids for chronic pain, contributing to a significant and alarming epidemic of opioid overdose deaths and addiction. Innovative scientific solutions to develop non-opioid, non-addictive alternative treatment options are thus urgently needed. One of the goals of the Helping to End Addiction Long-term (HEAL) Initiative is to accelerate the discovery and preclinical development of new medications and devices t...
Source: Videocast - All Events - Category: General Medicine Tags: Upcoming Events Source Type: video
AbstractIn 2015, the United States of America (USA) Department of Health and Human Services (HHS) released an issue brief that addressed opioid addiction, opioid overdoses, and opioid-related deaths as a public health concern within the country. After collaboration with state and stakeholder organizations, the HHS identified three target initiatives aimed to mitigate the negative consequences of opioid use within the USA. One initiative included implementation of guidelines to help reduce inappropriate opioid prescribing with a goal to reduce morbidity and mortality. The aim of this commentary is to discuss the misapplicat...
Source: International Journal of Clinical Pharmacy - Category: Drugs & Pharmacology Source Type: research
AbstractOpioid-related death and overdose have now reached epidemic proportions. In response to this public health crisis, the National Institutes of Health (NIH) launched the Helping to End Addiction Long-term InitiativeSM, or NIH HEAL InitiativeSM, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. Herein, we describe two NIH HEAL Initiative programs to accelerate development of non-opioid, non-addictive pain treatments: The Preclinical Screening Platform for Pain (PSPP) and Early Phase Pain Investigation Clinical Network (EPPIC-Net). These resources are pro...
Source: Neurotherapeutics - Category: Neurology Source Type: research
Abstract The opioid and pain crises affect every domain of family and community life with two million Americans living with opioid addiction, and 46,802 people dying from opioid overdoses in 2018 alone (National Center for Health Statistics, 2019). In addition, over 50 million Americans experience chronic pain, and half of those people suffer from chronic pain daily. Opioids are widely used to treat acute and chronic pain, and the lack of widespread access to nonpharmacological strategies to manage pain has contributed to the misuse of opioids. In fiscal year 2018, Congress added $500 million to the NIH's base app...
Source: The American Psychologist - Category: Psychiatry & Psychology Authors: Tags: Am Psychol Source Type: research
Abstract Chronic pain is considered a public health crisis due to its high prevalence, impact, costs, and disparities in pain prevalence and treatment. In parallel, drug overdose, particularly due to opioids, has become an epidemic in the United States, prompting a public health crisis concerning harms associated with both prescribed opioid therapy for chronic pain and illicit opioid use. The purpose of this special issue is to highlight state-of-the-art psychological research that addresses the combined issues of chronic pain and harms associated with opioids. Articles included in this special issue focus on 2 re...
Source: The American Psychologist - Category: Psychiatry & Psychology Authors: Tags: Am Psychol Source Type: research
Since 2000, the annual death toll from opioid associated overdose has increased by over 300%. To reduce the opioid consumption, physicians have used alternative approaches, which have proven to not only be effective, but also reduce the side effects such as nausea, constipation, and addiction. IV acetaminophen has been shown to successfully accomplish the reduction in opioid use, however, it is an expensive alternative. Testing the efficacy of IV acetaminophen vs its oral formulation will likely modify future postoperative pain management regimens while also addressing cost-effectiveness.
Source: The Spine Journal - Category: Orthopaedics Authors: Source Type: research
Abstract The misuse, abuse, and illicit use of prescription opioid analgesics is a global public health concern. However, there are many viable therapeutic options for the treatment of patients with chronic pain. Both intact and manipulated opioid drug products are abused by various routes such as oral, nasal, and injection which may lead to overdose, drug addiction, and even death. To combat the abuse of these medications, regulatory agencies and pharmaceutical companies are switching their interest towards developing Abuse deterrent formulations (ADFs), with the intent to deter the abuse of opioid products to a ...
Source: Current Drug Delivery - Category: Drugs & Pharmacology Authors: Tags: Curr Drug Deliv Source Type: research
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