USA – Consider a variety of endpoints for OUD treatments: FDA guidance

A new final guidance document from the US Food and Drug Administration (FDA) gives drugmakers considerations for choosing endpoints for new medications to treat opioid use disorder (OUD).

“We recognize that there’s great interest in developing new treatment options that result in meaningful outcomes, said FDA Commissioner Stephen Hahn, MD, in announcing the final guidance, which has only minor changes from an earlier draft version. “We know from research that treatment for OUD with both prescription drugs – including buprenorphine, methadone and naltrexone – and relevant social, medical and psychological services is a highly effective treatment,” said Hahn.