HealthDay News — The FDA has approved Zohydro ER (hydrocodone bitartrate extended-release) for severe pain that requires round-the-clock long-term treatment and for which alternative options are inadequate.

The Schedule II drug is the first hydrocodone-only product to receive FDA approval. Other hydrocodone opioids are combination formulations that also contain other non-opioid analgesics, such as acetaminophen.

“Due to the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain,” the agency said in a press release.

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The drug is not indicated for “as-needed pain relief,” the FDA said. 

The agency said it has ordered post-marketing studies of Zohydro ER to evaluate use beyond 12 weeks as well as its overall potential for abuse.

The most common side effects in clinical trials involving more than 1,100 people with chronic pain, included constipation, nausea, drowsiness, headache, dizziness, dry mouth and itching.

The FDA is taking steps to ensure all opioid drugs approved in the future contain built-in abuse-deterrent biochemical mechanisms, such as current extended-release formulations of OxyContin and Opana; however, Zohydro ER was approved without such safeguards. An abuse-deterrant formulation of Zohydro ER is in preclinical development.

Zohydro ER is produced by Zogenix, based in San Diego.

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