On August 29, the U.S. Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb released a statement that the agency is going to accelerate the development of non-addictive pain medications.
Over the last 17 months, the FDA has also focused on restricting the prescription of opioids and enforcing the sale of illicit opioids.
These efforts by the FDA are a part of the broader strategy to combat the opioid crisis outlined by the U.S. Secretary of Health and Human Services. This also coincides with the National Institutes of Health (NIH) initiative Helping to End Addiction Long-term (HEAL) Initiative which was introduced in April.
The HEAL Initiative is a three-pronged plan to enhance pain management. As a part of the Initiative, NIH will support research that seeks to understand the factors that lead to chronic pain and develop non-addictive pain medications.
The third part of the Initiative involves collaboration with the U.S. Food and Drug Administration and private sector companies to accelerate and incentivize the screening process of candidate non-addictive pain medications.
Accelerated screening methods include new pathways for manufacturers to obtain approval for their medications.
“New guidance we issued will expand the range of clinical endpoints that treatments for addiction can pursue, creating more opportunities for more efficient product development,” Gottlieb said.
The FDA plans to replace a 2014 guidance document with four new guidance documents that will reduce the number of required clinical studies. They will also release documents to advise manufacturers on the reduction of opioids in medications and to assist with the creation of non-opioid medications. Another document will help manufacturers assess the risks associated with the intentional misuse of new opioid medications.
The FDA has also been looking for non-medical approaches to treating pain. In May, the FDA launched an innovation challenge to encourage the creation of medical technologies to replace the systemic use of opioids.
“We’re hopeful that in collaborating with public health-minded innovators, we can identify and accelerate the development of new technologies, whether a device, diagnostic test, mobile medical app, or even new clinical decision support software, that can contribute in novel and effective ways to help reduce the scope of this crisis,” Gottlieb said in an FDA news release.
However, addressing the need for non-opioid pain medications may not be the only answer to the opioid crisis.
Opioid overdose deaths have occurred in three waves: The first, in the 1990s, was due to doctors overprescribing opioid pain medications. That being said, according to the data published on Centers for Disease Control and Prevention (CDC) website, the third, most recent wave is due to the increased availability of synthetic opioids.
Solutions to this issue, such as the development of non-addictive pain medications, address addictions formed in the medical setting.
Gottlieb acknowledged the changes in the crisis.
“We needed to broaden our approach as this crisis continues to evolve,” Gottlieb said in a FDA statement.
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