FDA to Help Opioid Manufacturers Make Abuse-Deterrent Medications

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Published: 11/22/2017 | Author:

The FDA recently announced that the agency will help drug manufacturers develop new, effective opioids that offer abuse-deterrent characteristics. In the U.S. there are roughly two million Americans diagnosed with painkiller use disorder, which was linked to nearly 38,000 overdose deaths in 2016. The FDA says this new move will help improve the nationwide opioid crisis by making it more difficult for painkiller users to abuse their medications.

What Are Abuse-Deterrent Opioids?

Abuse-deterrent opioids, also known as abuse-deterrent formulations or ADFs, are drugs with technologies designed to prevent people from abusing their medications. ADFs may have physical or chemical barriers that prevent the drugs from being crushed, dissolved, or grinded, or cause adverse side effects when used in ways other than directed. Some ADFs even have characteristics that render the drug useless and ineffective unless the drug is taken orally.

At present, ADF opioids are sold under brand names and significantly higher in cost than generic opioids. Many doctors tend to have a difficult time convincing patients to use these drugs on behalf of their higher costs, and also lack education surrounding their effectiveness. Some prescribers even remain unaware that ADF opioids exist in the first place, and are continuing to prescribe regular opioids that carry a higher risk for abuse.

Those who suffer painkiller use disorder will often crush, grind, or dissolve their medications so they can be injected or snorted. Misusing opioids in this manner can create a stronger high and more powerful effects. But those who start using ADF opioids will no longer be able to abuse their medications and experience euphoric effects — lowering the risk for dependence and addiction.

How will the FDA Help Drug Manufacturers with ADFs?

Abuse-Deterrent Medications

The FDA updated guidelines so manufacturers can make generic abuse-deterrent opioids.

In tandem with its new announcement, the FDA issued updated guidelines to help drug manufacturers develop generic versions of ADF opioids. The guidelines include new recommendations on how drug makers can produce effective generic ADFs at a lower cost than brand-name ADFs. The FDA also promised drug makers it would accelerate the regulation process surrounding these drugs so they can be marketed to consumers as quickly as possible when ready for distribution.

The FDA says this new solution could help lower painkiller addiction and overdose rates until new non-opioid forms of pain management are created or discovered. The agency also says it’s critical that drug makers and prescribers start encouraging the use of ADF opioids over regular opioids that pose a higher risk for abuse and dependence.

Treatment for Painkiller Addiction

Medication-assisted treatment for painkiller addiction is becoming more widespread to help Americans become healthier and addiction-free in wake of the U.S. opioid epidemic. Medication-assisted treatment, or MAT, involves the use of medications that completely eliminate opioid cravings and withdrawal symptoms. MAT allows patients to recover fully from painkiller addiction with less discomfort and a lower risk for relapse.

In addition to MAT, painkiller addiction can be safely and effectively treated using a medical detox or medically supervised detox in an inpatient treatment setting. These detox methods allow patients to withdraw from painkillers in safe, controlled medical environments surrounded by attentive nurses and doctors who monitor and oversee the detox process. Patients who seek MAT or professional detox treatment for opioid addiction can benefit from less pain and discomfort, a lower risk for relapse and overdose, and lifelong sobriety.

If you or a loved one needs help recovering from painkiller addiction, call our 24/7 confidential helpline at 800-483-2193(Who Answers?) to find the nearest opioid detox center. Our caring drug abuse counselors will discuss all your available treatment options, and provide you with the resources you need to become sober and addiction-free.

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