The FDA is working toward making therapies for opioid use disorder more readily accessible by advising pharmaceutical companies to limit the number of times they conduct clinical trials on particular proposed treatments.
The FDA published a draft guidance indicating that certain “depot buprenorphine products” may not require additional efficacy and safety opioid studies in certain instances because the agency may have approved a similar product that already underwent clinical testing.
“Unfortunately, far too few people who suffer from opioid use disorder are offered an adequate chance for treatment that uses safe and effective medications,” said FDA Commissioner Scott Gottlieb, MD, in a 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.”
On the other hand, if certain depot buprenorphine products require additional clinical testing, then drugmakers would have to show that their product is identical to the drug that has already been approved instead of proving that it is safe and effective.
The FDA will publish further guidance detailing the types of clinical outcomes that will be measured and evaluated for future treatment approvals.
