New FDA-Approved Opioid Deemed "Harder to Abuse"

The FDA has approved the opioid Hysingla ER (hydrocodone bitartrate) to treat chronic, “around-the-clock” pain. The drug features specific properties designed to deter, but not prevent, abuse.

The tablets of hydrocodone bitartrate are difficult to crush, preventing chewing or snorting, and form a thick, viscous gel making it difficult to prepare for injecting.

“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,” according to the FDA.

Hysingla ER is intended for use in patients for whom alternative treatments have proven inadequate, and not to be used for as-needed pain relief. It is available in 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg, and 120 mg tablets that are taken every 24 hours.

The FDA has required postmarketing studies to be conducted to evaluate the efficacy of the abuse-deterrent features of the drug.

Common side effects of Hysingla ER include fatigue, nausea, and upper respiratory tract infection.

—Michael Potts

Reference:

1. FDA. FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties [press release]. http://www.fda.gov.  Accessed November 21, 2014