FDA Releases New Draft Guidance for Drug Assisted Opioid Recovery

Federal health officials have released new scientific recommendations designed to encourage the development and improvement of medication-assisted treatment (MAT) for individuals suffering from opioid addiction, which causes roughly 42,000 overdoses annually in the United States.

In recognition of the opioid epidemic ravaging communities nationwide, the U.S. Food and Drug Administration (FDA) released a new opioid treatment draft guidance this week, which is aimed at developing more widespread innovation of medications for treatment of opioid use disorder (OUD).

According to the Substance Abuse and Mental Health Services Administration, regular adherence to MAT is the most effective method to help patients gain control over their use of opioids, and cuts the risk of mortality by nearly 50 percent.

Currently, opioid addiction is treated with Naltrexone, Buprenorphine, and Methadone, which have shown to be effective methods for treatment and helping individuals overcome their opioid addiction. The MATs act in a manner that stabilize the brain chemistry and reduce or block the euphoric effects of opioids, relieve physiological cravings, and normalize bodily function.

The FDA’s draft guidance outlines new ways for drug developers to consider measuring and demonstrating the effectiveness and benefits of new or existing MAT products.

Health and Human Services secretary, Alex Azar stated in the release that the new guidance has the potential to bring new medications to the market that are more closely tailored to patients needs to give patients a better chance at recovery.

The guidance not only offers direction on new drugs to assist patients in coming clean from opioids, but also offers ways to measure patient progress and wellbeing, such as the quickness to be able to return to work, school or other productive activity.

The U.S. epidemic of drug overdose deaths seems to only be worsening, Centers for Disease Control and Prevention (CDC) officials claimed in a prior release. There were nearly 50,000 drug overdose deaths in 2014, more than 1.5 times greater than the number of people killed in car crashes and 6.5 percent more than 2013.

Drug overdose deaths from opioid painkillers increased by 14 percent from 2013 to 2014. Officials found overdoses involving methadone stayed the same. A report released by the CDC in 2012, revealed methadone accounted for one-third of all deaths caused by opioid painkillers.

Recent studies have claimed the country’s opioid crisis is directly related to the excess opioids are often prescribed following hip and knee surgeries, and most patients who have hernia surgery can use lower doses. Other research warns that half of all patients prescribed narcotic painkillers don’t actually need them for pain relief.

In a report published in the medical journal Academic Emergency Medicine on April 2, researchers outlined the results of a 12 month data-driven intervention randomized trial of nearly 110 attending physicians, residents, and advanced practice providers at four emergency rooms in Colorado. In total, the doctors wrote more than 15,000 prescriptions for opioids. This represented about 20% of the prescriptions they wrote overall, citing a disproportionate and excess use of opioids.