FDA Approves First Single Entity Hydrocodone Painkiller ‘Zohydro ER’

The U.S. Food and Drug Administration on Friday approved a new drug- Zohydro ER- for the management of pain for which alternative treatment options are inadequate. This is the first FDA-approved single entity and extended-release hydrocodone product.

Belonging to the Schedule II controlled substance under the Controlled Substance Act, Zohydro ER will offer an additional therapeutic option to treat pain.  This is important as all individual patients respond to pain differently.  Zohydro ER (hydrocodone bitartrate extended-release capsules) is not combined with an analgesic like acetaminophen. This new drug belongs to the class of extended-release/long-acting opioid analgesics.

However, due to the risk of addiction, abuse and misuse with opioids even at recommended doses, FDA has placed Zohydro under stricter prescribing limits, by recommending it for those patients who don't respond to standard treatment.

Last month, FDA announced to update the labeling requirement for all ER/LA opiod analgesics. Zohydro ER will also provide the same labeling. This new class of labeling and stronger warnings will highlight the risk and safety concerns with all ER/LA analgesics. It will also clearly mention the appropriate use of the medications. With the new labeling requirement, Zohydro is the first drug to be released under the warning.

FDA has demanded postmarketing studies of Zohydro ER to analyze the risks of the misuse, abuse, increased sensitivity to pain, addiction, overdoes and death linked to the long term use (beyond 12 weeks). This postmarketing study is demanded from all other ER/ LA opioid analgesics.

To test the safety of the drug, a clinical study was done on more than 1,000 people suffering with chronic pain. The effectiveness of Zohydro ER was based on 500 patients suffering with chronic low back pain. They showed a significant improvement in chronic pain when compared to placebo.

Zohydro ER is manufactured by Zogenix. The drug causes common side effects like constipation, nausea, headache, fatigue, vomiting, dry mouth, itching and drowsiness.