Against chronic pain in the US opioids for 1 in 5 patients and the FDA takes corrective action
From the Food and Drug Administration guidelines to expand research on new therapeutic options by encouraging research on alternative analgesic drugs to be made available to prescribers
2' min read
2' min read
"The opioid crisis in America is not over. We must remain vigilant to address this long-standing problem in new ways. Doctors need more alternatives to opioid drugs for patients suffering from chronic pain. This is how Marty Makary, commissioner of the Food and Drug Administration (Fda), the regulatory agency for drugs in the United States, justifies the new guidelines that have just been drawn up to curb the still rampant abuse of these drugs in the country. Despite the crackdown imposed in recent years on what has been declared the most serious post-war public health emergency in the US, they continue to claim victims.
Few alternatives
.In spite of recent declines in consumption, the FDA explained in presenting the new measure, opioids remain commonly prescribed to about 1 in 5 adults in the United States living with chronic pain, as effective alternatives are limited. As part of its broader strategy to address the opioid crisis, the US agency has therefore published draft guidance entitled 'Development of non-opioid analgesics for chronic pain', aimed at accelerating safe and effective non-opioid treatments and reducing prescription-related opioid abuse.
"The FDA can help by providing clear guidance such as this, which makes regulatory pathways more predictable for innovators and drug developers, enabling effective, low-risk therapies to quickly reach the millions of Americans living with chronic pain," Makary further explains.
Serve strategy
.The Fda's broader strategy to deal with the opioid crisis, the US agency emphasises, 'includes calling for changes to safety labelling for opioid painkillers such as OxyContin to better reflect current evidence; strengthening enforcement of regulations on the importation and sale of illegal opioid products; and facilitating the development of non-opioid alternatives'.
The latest guidelines fulfil the mandate in the Support Act that requires the FDA to issue guidelines to help address challenges in the development of non-opioid treatments for pain management. It emphasises efficient approaches to drug development, with a focus on study design, appropriate patient populations and meaningful outcomes, such as reducing the need for opioid use.
