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FDA Broadens the Spectrum for Evaluating Treatments for Opioid Use Disorder

Jaime Rosenberg
Instead of assessing a treatment’s impact solely on reductions in opioid use, the agency will take into account the effect of the treatment on things like emergency room admissions and infectious disease transmissions.
In an effort to encourage the development of novel treatments for opioid use disorder, the FDA is expanding the way it evaluates the effectiveness and benefit of medication-assisted treatment (MAT) products.

Instead of assessing a treatment’s impact solely on reductions in opioid use, the agency will take into account the effect of the treatment on things like emergency room admissions and infectious disease transmissions.

“Treatments that can impact these aspects of addiction can be important parts of a comprehensive approach to the treatment of opioid use disorder,” said FDA Commissioner Scott Gottlieb, MD, in a statement. “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.”

MAT utilizes prescription drugs, such as buprenorphine, methadone, and naltrexone, to stabilize brain chemistry; reduce or block the euphoric effects of opioids; reduce the desire to use opioids; and normalize body functions.

The treatment is combined with counseling and other behavioral therapies as a comprehensive approach to treating patients with opioid use disorder. Regular adherence to MAT has demonstrated reductions in opioid withdrawal symptoms and cuts the risk of mortality from all causes in half.

The new draft guidance pinpoints several clinical endpoints for developers to utilize in addition to or rather than the current reduction in drug use. The effectiveness of the treatment can be measured by its impact on adverse outcomes, such as mortality (overall mortality or overdose mortality), emergency medical interventions, and Hepatitis C transmission.

Improvements in the ability to go back to school, work, or other productive activities may also serve as clinical benefits. There is also potential for patient-reported experiences, such as an urge to use opioids, to complement other endpoints.

With a broader spectrum of endpoints, the FDA noted that this could require larger clinical trials than typically conducted and encouraged sponsors to discuss their plans with the agency early in the drug development process.

While underscoring the importance of ensuring access to these treatments, Gottlieb also highlighted the need to address the stigma surrounding MAT. “We’re committed to doing our part to expand access to high-quality, effective MATs and encouraging healthcare professionals to ensure patients with opioid use disorder are offered an adequate chance to benefit from these therapies,” he said in a statement. “This work also includes improving understanding about the treatment options available for patients and countering the unfortunate stigma that’s sometimes associated with their use.

This push toward encouraging the development of MAT products comes shortly after the FDA’s approval of the first generic version of Subuxone (buprenorphine and naloxone) sublingual film and their reaffirmed commitment to improving access to prevention, treatment, and recovery options for those with opioid use disorder.

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