FDA to change how it evaluates addiction drugs

The FDA on August 6 shared a new draft guidance to promote the creation and more widespread use of medication-assisted therapies to treat opioid use disorder, according to STAT.

The draft guidance seeks to reframe how the agency will evaluate new treatments for opioid addiction. Instead of only assessing whether a treatment lowers opioid use, the agency will now analyze whether the medication could help lower overdose rates or limit spread of infectious diseases.

"We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission," Scott Gottlieb, FDA commissioner, said in a statement.

Medication-assisted treatment paired with psychosocial counseling is considered the standard of care for treating opioid use disorder. Three drugs cleared for MAT are buprenorphine, methadone, and naltrexone. However, patients often demonstrate poor adherence to the drugs, which addiction treatment experts say are greatly underutized in today's healthcare settings. The FDA seeks to expand and development more drugs beyond these three medications.

"The FDA's new guidances have the potential to bring new medications to market that are more closely tailored to patient needs and help give Americans facing addiction a better chance at recovery," HHS Secretary Alex Azar, told STAT.

The Senate also plans to further incorporate MAT as a key element in responding to the opioid epidemic.

More articles on opioids: 

FDA rejects Pain Therapeutics' opioid drug, shares plummet
FDA knew about dangerous opioid misuse, but failed to intervene, documents show
Children in these 3 states experience opioid-related parent loss, incarceration above the national average

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