FDA Approves Hard-to-Abuse Painkiller

Hysingla ER wins FDA approval to treat pain severe enough to require daily, long term opioid treatment

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new opioid painkiller — and this pill is thought to be difficult to abuse.

The FDA approved Hysingla ER (hydrocodone bitartrate), an extended-release opioid medication to treat patients with severe pain who need daily, around-the-clock, long-term opioid treatment.

Hysingla ER's label describes the medication's abuse-deterrent properties — that is, why it's hard to abuse the medication via crushing, snorting or injecting it. For one, the pill is difficult to crush. Also, it will turn into a thick gel if someone tries to prepare it for injection.

Almost 17,000 overdose deaths in 2011 were related to prescription opioid painkillers, according to the Substance Abuse and Mental Health Services Administration. The FDA and other organizations have called for pharmaceutical companies to make painkillers that are harder to abuse. Hysingla ER is the fourth medication with abuse-deterrent properties to get FDA approval, reports Bloomberg.

"While the science of abuse deterrence is still evolving, the development of opioids that are harder to abuse is helpful in addressing the public health crisis of prescription drug abuse in the US,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in an FDA press release. "Preventing prescription opioid abuse is a top public health priority for the FDA, and encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the agency to balance addressing this problem with ensuring that patients have access to appropriate treatments for pain."

Charles E. Argoff, MD, professor of neurology at Albany Medical College and director of the Comprehensive Pain Center at Albany Medical Center in New York, also highlighted this balance between the need to provide patients with effective painkillers while simultaneously preventing medication abuse.

"The burden of chronic pain and the abuse of prescription medications are both pressing societal problems," Dr. Argoff said in a press statement from Purdue Pharma, the company that makes Hysingla ER. "Opioids are an essential tool in our arsenal of medical treatment options, so greater availability and use of opioid analgesics with abuse-deterrent properties has the potential to help alleviate suffering among people with chronic pain while reducing the abuse of these medications. Furthermore, this product gives treatment providers the option to use hydrocodone without acetaminophen if they are concerned that their patients may be taking too much acetaminophen on a daily basis."

Unlike other common painkillers such as Vicodin, Hysingla ER does not contain acetaminophen, which can cause liver damage.

The FDA is requiring further research on Hysingla ER after it hits the market. The agency wants to see how well the abuse-deterrent features reduce the risk of abuse.

Review Date: 
November 20, 2014
Last Updated:
March 12, 2015