Abuse-Deterrent Opioids Bring Up Many Thorny Issues at FDA Hearing

A Food and Drug Administration (FDA) hearing last week revealed there are a number of disagreements among experts about abuse-deterrent opioids, MedPageToday reports.

The FDA has granted abuse-deterrent labeling to three drugs: Targiniq (oxycodone hydrochloride plus naloxone); Embeda (morphine plus naltrexone); and a reformulated version of OxyContin (oxycodone).

Drug companies that want to produce a generic opioid that competes with an abuse-deterrent brand-name opioid lack a clear set of rules to meet FDA expectations, the article notes. It is a challenge to develop a standard battery of tests to compare two drugs’ abuse-deterrent properties, experts said. In part that is because there are a number of ways these drugs can be abused, such as crushing a pill manually with a grinder, dissolving the drug in alcohol or water, or smoking it. There are also many ways to make the drugs harder to abuse, such as causing a burning sensation in the nose if the drug is inhaled, or making it harder for the particles to be absorbed.

Several speakers at the hearing expressed concern about limiting use of opioids that lack abuse-deterrent formulations. C. Bernie Good of the Department of Veterans Affairs noted the VA spends almost $89.4 million on drugs annually, primarily on generic drugs. He said more evidence is needed that using abuse-deterrent formulas are having the intended effect. He called for more studies “to know that we are benefiting society, and it’s not just decreasing the abuse in terms of crushing or snorting, but that actually at the end of the day, we have fewer deaths, fewer unintentional overdoses, et cetera, and that there aren’t unintended consequences like people going to heroin.”

Other speakers were concerned that removing non-abuse deterrent formulations would lead to a drug shortage or increase prices so much they would become too expensive for many patients. People who are determined to abuse drugs that cannot be ground or crushed could simply take more pills, some speakers noted.