Additional Progress on Reducing Abuse of Opioid Pain Relievers
FDA’s approval of the extended-release opioid pain medicine Hysingla ER (hydrocodone bitartrate)
marks additional progress in the fight against the ongoing misuse and abuse of prescription
opioids. Hysingla ER’s approval provides prescribers with another option for managing pain severe
enough to require daily, around-the-clock, long term opioid treatment in patients for whom
alternative treatment options are inadequate, while potentially reducing hydrocodone abuse.
In pre-approval testing, Hysingla ER exhibited properties that FDA expects will reduce the
likelihood users could abuse the drug by chewing the tablet and ingesting it orally, or crushing it
into powder for snorting or injecting. This is important because immediate-release combination
products containing hydrocodone are among the most frequently abused opioid products. Hysingla ER
is the fourth prescription opioid approved with product labeling that is consistent with the FDA’s
2013 guidance on abuse-deterrent opioids.
While Hysingla ER has the same active ingredient (hydrocodone) as Zohydro ER, the only other
approved extended-release hydrocodone product, there are important differences between the two.
Hysingla ER has approved abuse-deterrent labeling, while Zohydro ER does not. Also, Zohydro ER is
taken every 12 hours, and so comes in lower dosage strengths than Hysingla ER, which is taken every
24 hours. FDA has not yet determined whether Hysingla ER will prove to be safer than Zohydro ER.
Notes Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, FDA, “Prescription
opioids with abuse-deterrent properties will not completely fix the prescription opioid abuse
problem, but they can be part of a comprehensive approach to combat the epidemic. And the
development of abuse-deterrent opioids is only one of many elements of FDA’s overall approach,
which includes provider and patient education, close monitoring of approved opioids, and review and
approval of drugs to treat addiction and prevent overdose.”
NCPIE encourages healthcare professionals and community groups to foster patient–professional communication about medicines. However, NCPIE does not supervise or endorse the activities of any group or professional. Discussion and action concerning medicines are solely the responsibility of the patient and their healthcare professionals, and not NCPIE.
Please consult a licensed health care professional with questions or concerns about your medication and/or condition.