FDA Takes Steps To Encourage Development Of Medication That Can Be Used To Aid Addiction Treatment
Currently, just three drugs exist to treat opioid use disorder: buprenorphine, methadone, and naltrexone. Adherence to the drugs is typically low, and addiction treatment experts have long said medication assisted treatment is vastly underutilized.
The Hill:
Trump Officials Take New Step To Encourage Opioid Abuse Treatments
The Food and Drug Administration (FDA) on Monday took a step to encourage the development of more drugs to treat opioid addiction. The FDA issued guidance to encourage the development of more drugs that can be used in what is known as Medication Assisted Treatment, a leading way to treat people with opioid addiction, through using certain drugs to reduce dependence on opioids. (Sullivan, 8/6)
Stat:
FDA Will Expand The Way It Considers Medication-Assisted Treatment
Now, rather than merely examining whether a potential treatment reduces opioid use, the agency will consider factors like whether a drug could reduce overdose rates or the transmission 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,” FDA Commissioner Scott Gottlieb said in a statement. (Facher, 8/6)
Modern Healthcare:
FDA Gives Drugmakers New Ways To Prove Opioid Disorder Treatments Work
The recommendations follow earlier draft guidance the agency released in April that outlined the FDA's current position on drug development and trial design issues as related to the study of new buprenorphine products. In that document, the agency suggested some of those products—such as extended-release versions and implants—may not need new safety and efficacy clinical trials such as those for new drugs seeking regulatory approval. Both documents reflect a noticeable shift in the FDA's position related to the drug approval process. The agency is opting for shorter studies and faster approvals for new medication-assisted treatments as the opioid epidemic continues to impact the nation, causing more than 42,000 deaths in 2016 and a 30% rise in emergency department visits from 2016 to 2017 across 45 states. (Johnson, 8/6)
Meanwhile —
The Associated Press:
Jails, Prisons Slowly Loosen Resistance To Addiction Meds
Four inmates sit silently in the library of the Franklin County House of Correction one summer morning. But these men aren't here to read books. Under the supervision of a nurse and two corrections officers, they're taking their daily dose of buprenorphine. The drug, often known by the brand name Suboxone, is meant to control their heroin cravings and is commonly smuggled into jails and prisons. (8/7)
