Prince’s music and his cause of death will never be forgotten. But what about the two million other people in the United States who suffer from substance use disorders related to prescription opioid pain relievers? According to FDA commissioner Robert M. Califf, M.D., the public health crisis of opioid misuse, addiction and overdose is one of the most challenging issues facing the FDA.
The addiction to opioids such as heroin, morphine and prescription pain relievers has been a serious global problem for years, and there could be anywhere from 26 to 36 million people worldwide who abuse opioids, according to the National Institute on Drug Abuse (NIDA). The number of unintentional overdose deaths from prescription pain relievers has soared in the U.S., more than quadrupling since 1999, NIDA says. In 2015, 91 Americans died from an opioid overdose each day.
Several factors have contributed to the severity of the current prescription drug abuse problem, NIDA says. They include drastic increases in the number of prescriptions written and dispensed, greater social acceptability for using medications for different purposes and aggressive marketing by pharmaceutical companies. According to NIDA, opioid prescriptions grew from about 76 million in 1991 to nearly 207 million in 2013, with the U.S. being their biggest consumer globally.
The FDA has taken a number of actions to help reduce prescription opioid addictions and overdoses. They have improved product labeling, pushed for prescriber education and encouraged the development of abuse-deterrent formulations. In addition, the FDA has approved new intranasal and auto-injector forms of naloxone — products to reverse opioid overdoses — which can be administered not only by first responders, but also the general public, and are more readily available.
For naloxone to reverse an opioid overdose, however, it must be administered quickly. That’s why the FDA launched the Naloxone App Competition late last year, in an effort to develop a solution to the problem of how to quickly connect naloxone carriers to a person experiencing an opioid overdose. The winner of that competition was OD Help by Team Pwrdby, a startup based in Venice, California, that took home the $40,000 prize. OD Help’s concept is a simple, easy-to-use mobile app designed to connect potential opioid overdose victims with a crowd-sourced network of naloxone carriers.
The FDA has also partnered with other federal agencies to address the problem, but more work needs to be done.
“Public and private sector efforts in this area must be continued and strengthened,” Califf says. “In particular, I want to call on the pharmaceutical companies that manufacture and sell these drugs to dig deeper into their expertise and resources to prioritize finding solutions to this public health problem…This is the time for both branded and generic drug companies to go beyond marketing and distribution plans and instead commit their expertise and resources to confronting the devastating negative consequences of a class of drugs that brings much needed pain relief, when used appropriately.”
To Califf’s point, the pharma industry already is addressing the opioid epidemic a few ways:
1. Researching and developing new abuse-deterrent formulations. For example, Catalent has done significant research toward abuse-deterrent softgel technology, so that the API cannot be extracted and injected. Drugmakers have also made uncrushable versions of opioids.
2. Some pharma companies have changed their marketing tactics. Pfizer, for example, has agreed to disclose in its promotional material that narcotic painkillers carry serious risk of addiction — even when used properly.
3. Manufacturers are researching alternative pain treatments. For example, biotech companies, including Genentech and Biogen, are developing drugs that relieve pain without the risk of addiction.
That said, a comprehensive solution will likely require all the major players to help solve the problem — drug companies, prescribers, insurers and the FDA.