Abuse-Resistant Prescription Painkiller Approved

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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.

Source: HealthDay

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