FDA takes new steps to encourage the development of novel medicines for the treatment of OUD

In an effort to promote more widespread innovation and development of novel medication-assisted treatment (MAT) drugs for opioid use disorder (OUD), FDA issued new scientific recommendations on Monday.

In an effort to promote more widespread innovation and development of novel medication-assisted treatment (MAT) drugs for opioid use disorder (OUD), FDA issued new scientific recommendations on Monday. New draft guidance highlights new ways for drug developers to consider measuring and demonstrating the benefits and efficacy of new or existing MAT drugs. "This new guidance is an important step in fostering the development of new treatment options that help patients achieve these and other real-world outcomes, by providing a pathway for how innovators can use these clinically relevant measures as part of new drug development programs," said FDA Commissioner Scott Gottlieb, MD. "We're committed to doing our part to expand access to high-quality, effective medication-assisted treatments and encouraging health care professionals to ensure patients with opioid use disorder are offered an adequate chance to benefit from these therapies." While a reduction in drug use patterns is generally used as an endpoint in clinical trials to evaluate the effectiveness of MAT for the purposes of FDA approval, the draft guidance lists several other potential clinical endpoints and outcome measures that could be used. FDA is urging sponsors to talk to the agency early on in the drug development process, and it noted its commitment "to providing assistance to sponsors interested in developing a validated measurement of patient-reported experiences, such as 'craving' or 'urge to use' opioids, which make it difficult for patients with OUD to sustain recovery."