FDA Approves New Hard-to-Abuse Opioid

By: Ankur Dave, RPh, Director of Clinical Services and Quality Assurance

On Thursday November 20th, 2014 the FDA approved the first hard-to-abuse version of hydrocodone. Branded as Hyslinga ER by Purdue Pharma, the painkiller is indicated for patients with severe, round-the-clock pain that cannot be controlled with alternative treatments. Current dosing recommendations are listed as once daily but may be subject to change once more studies are done.

According to the FDA, Hysingla ER contains properties that will reduce the abuse of the drug if chewed, crushed, snorted, or injected. The medication, which is difficult to break or dissolve, also forms a viscous hydrogel, making it difficult to prepare for injections. However when taken orally these medications can still be abused.

The goal is to limit the various ways in which people abuse opioids. As Janet Woodcock, MD, Director of the FDA’s Center for Drug Evaluation and Research states, “Although 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 United States.”

The company expects to launch the new product in the United States early in 2015 in multiple dosage strengths between 20 mg and 120 mg to be taken once every 24 hours. Unlike many other hydrocodone formulations, Hysingla ER will not contain any acetaminophen, which is a leading cause of acute liver failure in the US, according to Purdue.