Publication date: Aug 07, 2018
The Food and Drug Administration wants to get more companies to make drugs that can help treat opioid addiction.
The agency sent out new recommendations on Monday for medication-assisted treatment drugs with the goal of approving more of them. The recommendations come as Congress is hoping to expand access to such drugs as a way to combat the opioid epidemic.
-The evidence is clear: medication-assisted treatment works, and it is a key piece of defeating the drug crisis facing our country,” Health and Human Services Secretary Alex Azar said in a statement. -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.”
More than 42,000 people died from opioid overdoses in 2016, according to the National Center for Health Statistics.
Examples of medication-assisted treatment include buprenorphine, methadone, and naltrexone. The drugs help to reduce or block the euphoric effects of an opioid high and relieve cravings for taking the drugs.
Congress has taken several steps to expand access to medication-assisted treatment. The House passed legislation in June to expand the authority to prescribe buprenorphine to nurse practitioners and physician assistants in addition to doctors.
[Also read: Lawmakers aim to stop use of pill machines used to boost opioid epidemic]
The regulatory guidance documents released by the FDA are meant to make it easier to conduct clinical trials for medication-assisted treatments.
For instance, normally a clinical trial required for FDA approval has to show that a new treatment caused a person to reduce opioid use. The new guidance said that there are other outcomes from a clinical trial that a drug maker can consider to get FDA approval besides just reduction in drug use.
The agency also wants drug makers to talk with the agency earlier in drug development to iron out any future problems.
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