NIH Announces Plan to Manage Opioid Crisis. The National Institutes of Health (NIH) reports that, as of June 2017, two million people have a prescription opioid use disorder; another 591,000 suffer from a heroin use disorder.
Opioid prescription drug misuse has cost the United States $78.5 billion in healthcare, law enforcement, and lost productivity. According to the NIH, “We understand ‘opioid’ addiction better than many other drug use disorders; there are effective strategies that can be implemented right now to save lives and to prevent and treat opioid addiction. At the National Rx Drug Abuse and Heroin Summit in Atlanta last April, lawmakers and representatives from health care, law enforcement, and many private stakeholders from across the nation affirmed a strong commitment to end the crisis.”
Research is believed to be an important element in achieving the NIH’s goals and is part of the plans the NIH laid out to push research in three areas, according to its piece in the New England Journal of Medicine. The three areas include overdose reversal, addiction treatment and pain management.
Additional overdose-reversal interventions and improved formulations of naloxone to reduce mortality need to be developed, according to the NIH. Naloxone, which is known under the brand names Narcon and Enzio, has been found to be effective at reversing ‘opioid’ overdoses; however, bystanders may not reach the overdosing individual in sufficient time and available doses may not be powerful or enduring enough to reverse fentanyl and other extremely potent synthetic opioid overdoses. Research should also be developed for technologies to detect an overdose, signal for help, and automatically intervene to stimulate respiration. The NIH also notes that better strategies should be developed to successfully involve individuals who have overdosed in addiction treatment.
The NIH noted that “new, innovative medications and technologies to treat opioid addiction” are needed. The existing opioid agonist-methadone-; the partial agonist-buprenorphine-; and the antagonist-naltrexone-all effectively minimize illicit opioid use, but only when provided at an adequate dose and when patients follow their treatment plan. The NIH notes that not all patients respond to these medications.
The NIH also pointed out that its “growing knowledge of the neurobiology of opioid addiction has helped researchers to identify” new “molecular targets.” The NIH also indicated that there are new ways in which to modify brain circuits to produce more effective, safer treatments for opioid use disorders, including vaccines that engage the body’s immune system to stop opioids from entering the brain. In fact, these vaccines have shown “shown great promise in animal studies.”
Safe, effective, non-addictive treatments are also needed to manage chronic pain. There were close to 20,000 overdoses in 2015 over heroin or fentanyl. The path of opioid addiction typically starts with prescription opioid misuse. For example, some individuals with an opioid addiction began by taking pills from friends and family, while others start with their own opioid prescription.
Other entities, including the U.S. Centers for Disease Control and Prevention (CDC), have suggested reducing medical use of addictive prescription opioids, which would reduce the drugs’ supply. This does not speak to the real issue of untreated pain nationwide, “and we”-the NIH-“cannot solve the opioid addiction and overdose crisis without better addressing pain at the same time. New pain treatments need to be developed.”
The NIH wrote that, “Extraordinary focus is being brought to the opioid crisis by all segments of our society, so now is the time to leverage this awareness to accelerate the pace of research to develop new treatments.”
Parker Waichman LLP has spent decades representing clients in drug injury lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing an opioid lawsuit.
Ohio Lawsuit Brought Over Deceptive Opioid Marketing
A deceptive opioid drug marketing lawsuit has been brought against five prescription opioid manufacturers. Allegations include fraudulent marketing and misrepresentation of the risks tied with these drugs, especially addiction risks, as well as false marketing, including medical journal advertising, sales representative statements, and the use of front groups to deliver information minimizing risks and overstating benefits of specific opioid formulations. Also, according to allegations, this behavior multiplied opioid prescriptions, adding to the epidemic. The lawsuit has been filed in Ohio.
The suit names Purdue Pharma, marketer of OxyContin, MS Contin, Dilaudid, Butrans, Hyslingla, and Targiniq; Endo Health Solutions, the marketer of Percocet, Percodan, Opana, and Zydone; Teva Pharmaceutical Industries and its subsidiary Cephalon, the marketers Actiq and Fentora; Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, marketers of Duragesic and Nucynta; and Allergan, marketer of Kadian, Norco, and various generic opioids.
FDA Announced Endo Pharmaceuticals Must Remove Opioid from the Market
The U.S. Food and Drug Administration (FDA) just announced that drug maker, Endo Pharmaceuticals must remove its powerful ‘opioid’ painkiller Opana ER (oxymorphone hydrochloride) from the market, according to CNN. The agency noted that this the first time it has asked that an opioid pain medication to be pulled due to “the public health consequences of abuse.”
“We are facing an opioid epidemic-a public health crisis-and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” FDA Commissioner Dr. Scott Gottlieb said. “We will continue to take regulatory steps when we see situations where an ‘opioid’ product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”
CNN points out that Opana ER is twice as strong as OxyContin and is prescribed to manage pain that it is serious enough to mandate daily, around-the-clock, long-term ‘opioid’ treatment for which alternatives are not strong enough, according to the manufacturer’s website. The FDA approved it for this use in 2006.
Endo attempted to make the drug more difficult for addicts to use by making Opana ER with a coating, rendering the drug difficult to crush. The medication is meant for time release; however, addicts had been crushing the drug to get a large high at one time. The FDA indicated that its latest decision was based on a review of all Opana ER post-market data that suggested that when Endo reformulated the medication, people were injecting, more than snorting the ‘opioid’, leading to a significant outbreak of hepatitis C and a serious blood disorder, the agency noted. When Endo submitted its re-formulated version of Opana ER to the FDA in 2012, the agency believed data were not strong enough to prove the drug could “meaningfully reduce abuse.” The agency denied a request for a label describing its reformulation as having abuse-deterrent properties.
Endo is reviewing the FDA’s request and evaluating all its options “as we determine the appropriate path forward,” it said in a statement.
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