USA – FDA Finalizes Buprenorphine Drug Development Guidance

The US Food and Drug Administration (FDA) on Wednesday finalized guidance on developing new types of buprenorphine depot products for medication assisted treatment (MAT) for opioid use disorder amid the ongoing opioid epidemic.

Buprenorphine, along with methodone and naltrexone, are the only drugs approved by FDA to treat opioid use disorder.

Buprenorphine MAT works by reducing patients’ withdrawal symptoms and blocking the euphoric effects of other opioid drugs. With the newly finalized guidance, FDA hopes to promote the development of new modified-release buprenorphine products for injection or implantation. Such products would allow for passive compliance by patients and could lead to better outcomes than self-administered MAT products.

“We’re in urgent need of new and better treatment options for opioid use disorder. The guidance we’re finalizing today is one of the many steps we’re taking to help advance the development of new treatments for opioid use disorder, and promote novel formulations or delivery mechanisms of existing drugs to better tailor available medicines to individuals’ needs,” said FDA Commissioner Scott Gottlieb.

Gottlieb also took aim at private insurance companies, who he said often provide “inadequate” coverage for MATs. “Far too few people who are addicted to opioids are offered an adequate chance for treatment that uses medications,” he said. Despite gains made at the state level, Gottlieb also pointed out that many public insurance plans do not cover all FDA-approved addiction treatments…