Abuse-Resistant Prescription Painkiller Approved

The U.S. Food and Drug Administration has approved Hysingla ER (hydrocodone bitartrate), an abuse-resistant, extended release form of the painkiller hydrocodone (best known as Vicodin).

The drug is sanctioned for long-term severe pain that requires daily, around-the-clock treatment. The tablet is difficult to crush, break or dissolve, making it resistant to abuse, the agency said Thursday in a news release.

But the medication can still be abused, and an overdose can lead to death, the FDA warned.

Hysingla ER shouldn't be used for "as-needed" pain relief, the agency added.

The drug's safety and effectiveness were evaluated in clinical studies involving 905 people with chronic lower-back pain. The most common side effects were constipation, nausea, fatigue, upper respiratory tract infection, dizziness and headache.

The FDA said it has ordered a post-marketing study to further assess the drug's potential for abuse. Hysingla ER is produced by Purdue Pharma, based in Stamford, Conn.

More information

The FDA has more about this approval.