A board-certified addiction medicine physician, Kathleen Whaley, MD, has provided medication-assisted treatment at a number of New York and Indiana hospitals. Kathleen Whaley, MD, remains active in her field as a member of the American Society of Addiction Medicine’s national and Indiana chapters.
In August 2018, the U.S. Food and Drug Administration issued new recommendations for the approval of medication-assisted treatment drugs. The changes are geared toward encouraging the development of more products to treat opioid use disorder and increase the use of medication-assisted treatment (MAT). By helping participants control their opioid use disorders, MAT reduces these individuals’ risk of death by 50 percent.
In the past, clinical trials have evaluated the effectiveness of MAT drugs by assessing how well they reduce drug use for participants. The new guidelines identify additional clinical goals and outcomes, which expands the possibilities that pharmaceutical companies have for assessing the benefit of potential MAT drugs. New goals include lower mortality rates, fewer overdoses, and a reduced need for medical interventions.
Reduced opioid use remains a potential goal for evaluated drugs. Drug developers who target this endpoint can assess the percentage of patients who qualify for a diagnosis of moderate to severe opioid use disorder at the outset, but may be classified as in remission by the end of treatment. An increase in a patient’s level of functioning may also serve as evidence of positive outcomes.
