Steve Pasierb on FDA Approval of Hysingla

This week, a new extended-release opioid pain medicine with abuse deterrent properties by the name of Hysingla was approved by Food and Drug Administration (FDA). The FDA sees this new product’s approval as a step toward addressing the issue of misuse and abuse of prescription opioids.  The tablets cannot easily be broken, crushed into powder or dissolved in a manner permitting a quick release of the opioid contained within.  These are the primary approaches taken by those who seek to snort or inject a prescription pain medication to get high.  To be clear, this product is expected to reduce, but not completely eliminate abuse as it is still possible to simply ingest too many pills or too high of a dosage risking overdose.

The full range of medicine abuse behavior is a problem of such a large scale in this country that overdoses involving prescription drugs have been classified an epidemic by the CDC.  And, we at the Partnership have been on the record advocating that it is crucially important to only approve new products with abuse deterrent properties.  We’ve expanded on that by saying our nation needs to go further, moving to reformulate all prescription medicines that hold the potential for abuse.  Previously, we advocated to the FDA urging them not to approve Zohydro ER – a long-acting, pure form of the painkiller hydrocodone – for marketing without requiring it to have tamper-resistant features.

Before Hysingla, two other opioids OxyContin and Opana ER were reformulated in this manner, and we’ve seen early signs that the versions of both of these products are being abused less, according to reports from Poison Control Centers and drug treatment facilities. If all extended-release opiate products were required to incorporate tamper-resistant technology in the manner of those drugs, and now Hysingla, we believe that we would start seeing a beneficial societal impact of less abuse of opioid products, fewer prescription drug overdoses and fewer deaths.

As a public policy matter, we should all be encouraging companies to “retrofit” their current products so that they are more difficult to abuse, following the example of OxyContin, Opana and now Hysingla.

For more perspective on this issue, a blog post by the Director of FDA’s Center for Drug Evaluation and Research, Janet Woodcock, M.D. , provides additional insight into the agency’s views on approval, as well as the overall issue of opioid abuse and still-needed advances in abuse deterrence.  It’s well worth a read.

At the Partnership, we know that everyone has a role to play in preventing prescription drug abuse – a devastating behavior that often begins in the teen years. To reverse the epidemic, the Partnership launched The Medicine Abuse Project, a multi-year action campaign aiming to prevent half a million teens from abusing medicine. Through this campaign, we educate parents, educators, communities, health care providers and others to take action and do their part in ending medicine abuse, particularly among teens.