Gottlieb unveils guidance for opioid dependence treatments

As part of an effort to address the opioid abuse epidemic, FDA released draft guidance for the development and clinical trial design of sustained-release depot buprenorphine products -- modified-release medication-assisted treatments (MATs) for injection or implantation to treat opioid use disorder.

In a statement, FDA Commissioner Scott Gottlieb said one way FDA can address the issue of opioid misuse and abuse is to encourage innovation and development of MATs, which studies have shown are safe and effective to treat opioid addiction when combined with counseling and psychosocial support...