The Food and Drug Administration on Friday encouraged drugmakers to conduct fewer clinical trials on certain proposed medication-assisted therapies for opioid use disorder, saying a streamlined approach will help patients access treatment quicker.
In a draft guidance released Friday, the FDA said some so-called "depot buprenorphine products" don't need new safety and efficacy clinical trials, a move that could avoid unnecessary duplication of studies performed on a similar product the agency already approved. These drugs include extended-release buprenorphine injections and implants that patients take once a month rather than daily.
"Unfortunately, far too few people who suffer from opioid use disorder are offered an adequate chance for treatment that uses safe and effective medications," FDA Commissioner Dr. Scott Gottlieb said in a written statement. "The FDA will continue to encourage more widespread innovation and development of new and better treatments for opioid addiction as well as tackle the unfortunate stigma that's sometimes associated with use of these treatments."
The suggested pathway for some depot buprenorphine products is similar to the FDA's process to approve generic drugs. Drugmakers would have to prove that their product is equivalent to the original drug rather than showing it's safe and effective.
The FDA will assess how long it takes for these therapies to be absorbed in a patient's bloodstream, estimated time to clear a patient's system and other similarities to products already on the market.
The FDA said it will issue additional guidance that will outline the types of clinical outcomes that will serve as the basis for approving future medication-assisted therapies. Aside from their ability to reduce opioid use, the drugs could be measured by how they reduce cravings or improve patients' sleep and mood patterns.
Buprenorphine use has dramatically spiked over the past decade as healthcare providers encounter increasing numbers of opioid disorder cases. Approved by the FDA in 2002, the drug remained relatively unchanged as a daily oral dose until 2010, when the agency approved a version of buprenorphine that could be placed under the skin.
In 2016, the FDA approved a buprenorphine implant that provides low-level doses of the drug over six months, and last November, the agency approved the first injectable form of buprenorphine to be sold, which can be taken once a month.
The increased demand for extended-release buprenorphine stems in part from poor adherence rates among patients who take daily doses of buprenorphine. Fewer than 50% of opioid use disorder patients receiving buprenorphine daily adhered to their treatment regimen, according to a 2016 study published in the American Journal on Addictions.
The guidance is the latest FDA action in recent months to address the opioid crisis. On Tuesday, the agency hosted a Patient Focused Drug Development meeting to hear patients' perspectives on opioid use disorder, and their experiences using prescription medical treatments for their disorder.
