FDA and Pharma commit to balanced solutions to curb addiction, treat pain.
By: Sidney H. Schnoll, MD, PhD and Jack Henningfield, PhD
With opioid abuse and misuse continuing to be a public health problem in the U.S., there is an urgent need for balanced, commonsense solutions to address this ongoing public health problem without abandoning those who legitimately need pain relief. Since 1999, the rate of opioid-related overdose deaths has quadrupled in the U.S., resulting in the deaths of more than 70 people per day as reported by the Centers for Disease Control and Prevention in its “Data Overview: Overview of an epidemic” report. Yet, there are still those - 38 million Americans - who need strong pain relievers, such as opioids, to ease their debilitating chronic pain so they can work, care for their families, and live a normal life, less compromised by pain.
The heightened media, political and public attention on the issue often distorts the facts, which has made it easy to blame one side or the other, but a balanced approach is critical and a collective understanding that something needs to change is undeniable (Scholten and Henningfield, 2015, 2016). This has been the approach of the World Health Organization in its efforts to ensure appropriate access to opioid analgesics to relieve pain while balancing controls to reduce the risks of abuse and diversion.
In addition to the World Health Organizationcollective efforts are also needed from organizations like the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and the pharmaceutical industry, as well as physicians, patients, family members, non-profit organizations and others.
One important approach is creating medicines that provide pain relief while reducing the potential for abuse. FDA has been instrumental in supporting the development of abuse deterrent medicines at the same time that many science-based research and development companies are investing in such innovations. The commitment to developing abuse deterrent, chronic pain medicines is an important step towards reducing abuse of prescription opioids.
ONE MASSIVE PROBLEM, MANY PARTS
Of the many components to the opioid abuse epidemic, there are two distinct issues concerning FDA and pharma, and at the same time driving innovative solutions.
The first is the abuse of prescription pain relievers by those who were never given a prescription. From the National Survey on Drug Use and Health, an estimated 70 percent of Americans who have reported using opioids non-medically admitted they obtained the drug for free from friends or family members, or through theft or purchase.
Many of the reported deaths from overdoses occur in individuals who never received a prescription for opioids, and frequently involve multiple drugs. Of those who have received prescriptions, many have histories of abuse of drugs prior to getting the prescription and once again, often involve multiple drugs.
The second part is the issue of individual pain management. Today, more than 100 million Americans are dealing with some form of chronic pain. The consequences of inadequately treated pain include decreases in the ability to work and participate in social activities, and overall reductions in quality of life. All too frequently, people with chronic pain seek out illicit opioids when prescription relief is difficult to access, and suicide occurs too frequently when pain relief is unavailable. While there are alternative solutions such as physical therapy and over-the-counter medications (like ibuprofen) that can help, management of pain needs to be tailored to the individual.
FDA is attempting to incentivize pharma to look farther and more innovatively toward solutions that will help pain sufferers, while reducing the likelihood of abuse. FDA’s 2015 “Guidance to Industry on Abuse Deterrent Opioids” implies a stick and carrot approach. The stick is tougher criteria for evaluating the abuse potential of opioids, and presumably for their approval with increased evaluation by external expert advisory committees. The carrot is the potential for labeling that acknowledges some level of abuse deterrence as supported by extensive evidence. Although not a focus of this article, developing approaches to this problem must include not only the development of safer pain medications, but to ensure appropriate availability of treatment for those who suffer from a substance use disorder.
PROGRESS IS MADE FARTHER WITH TEAMS
For years, the FDA has taken a positive and collaborative approach to encourage pharmaceutical companies to continue researching and developing alternative solutions to today’s opioids. As a result, six abuse deterrent formulation medications have been approved by the FDA. These select therapies may reduce some methods of abuse, and still provide pain relief. As the FDA has provided guidance and incentives to approve new, less addictive medications for pain management, biotech companies focused in the space continue to innovate and invest in the development of new reduced-abuse therapies.
Today, many companies working to provide patients an alternative pain relief method utilizing next-generation solutions – such as Collegium Pharmaceutical, Inc., Depomed, Inc., Egalet Corporation, Nektar Therapeutics, Pfizer, Inc., Purdue Pharma and Sanofi. These “next-generation” solutions are looking to stem abuse with new, abuse deterrent formulations and new chemical entities that mitigate the risk of abuse. Nektar Therapeutics, for example, created an entirely new opioid molecule specifically designed to enter the brain much more slowly so as not to trigger a rapid “dopamine rush” or “high” sensation, while still acting on the receptors that relieve pain in the body. Solutions such as Nektar’s are another step closer to providing patients in need of chronic pain relief, at the same time reducing the want and need for patients to abuse opioid therapies.
LONG WAY TO GO, BUT WE’RE GETTING CLOSER
In reality, innovation takes time, and a solid solution will not happen overnight. The College on Problems of Drug Dependence was formed in 1927 to develop non-addictive opioids and non-addictive alternatives for treating pain. We are still searching for that product. For now, prescribers should put the care of their patients first while trying to not fuel harmful use by others. This can include providing the most appropriate medications to treat their pain, along with information and guidance to minimize the risks and harmful use, diversion and overdose, and referring those in need to appropriate treatment for their substance use disorder. Such practice skills can also limit the potential for misuse and leftover medication. Extensive guidance and advice is now available from FDA, CDC, and other sources at the resources listed below and increasingly in the form of expert review articles and commentaries.
For more information about opioids, substance abuse and how you may be able to prevent the issue from happening to someone close to you, please use the following guides:
Additional Educational Resources
- “Opioid Prescribing for Chronic Pain — Achieving the Right Balance through Education,” by Daniel P. Alford. The New England Journal of Medicine. 2016 February 3
- “Letter to the Editor: A meta-analysis based on diffuse definitions and mixed quality literature is not a good fundament for decisions on treatment of chronic pain patients,” by Willem Scholten and Jack E. Henningfield. PAIN. August 2015.
- “Negative outcomes of unbalanced opioid policy supported by clinicians, politicians, and the media. Journal of Pain & Palliative Care Pharmacotherapy,” by Willem Scholten and Jack E. Henningfield. Journal of Pain & Palliative Care Pharmacotherapy. 2016 February 18.
Disclosure: We acknowledge the assistance of Pure Communications, Inc., which was supported by Nektar Therapeutics for their help in the development of this article.
Jack Henningfield, PhD is a leading expert on addiction and abuse of prescription medications and illicitly manufactured substances of abuse. He is former head of the National Institute on Drug Abuse laboratory that conducted abuse and addiction liability studies and presently consults to pharmaceutical companies on the development of medicines with reduced potential for abuse.
Sidney H. Schnoll, MD, PhD is an internationally recognized expert in addiction and pain management who applies his experience of over 30 years in academic medicine to the issues of risk management. He has served on numerous committees and boards including the FDA’s Drug Abuse Advisory Committee (DAAC), NIH study sections, National Board of Medical Examiners test development committees, and the board of the College on Problems of Drug Dependence (CPDD).
Pinney Associates consults with pharmaceutical companies including Nektar Therapeutics and other companies mentioned in this article that market a wide variety of prescription and over-the-counter medications including prescription opioids and stimulants. However, no financial support was provided to the authors for the preparation of this article.