The FDA has approved an extended-release oral formulation of the opioid agonist hydrocodone (Zohydro ER – Zogenix) for management of pain severe enough to require continuous, long-term therapy and for which alternative treatment options are inadequate. Zohydro ER is the first single-ingredient hydrocodone product to be marketed in the US. Hydrocodone has been available for years in combination with acetaminophen (Vicodin, and others) or ibuprofen (Vicoprofen, and others).

The FDA has approved an agonist/antagonist combination of morphine and naltrexone (Embeda – King) for treatment of chronic moderate to severe pain requiring around-the-clock analgesia for an extended period of time. The addition of naltrexone is intended to prevent abuse of morphine.

The Medical Letter review of Palladone (hydromorphone HCl) extended-release capsules (March 14, 2005) warned that a lethal dose could be released if the new formulation was taken with alcohol. Because of that risk, the FDA asked the manufacturer (Purdue) to withdraw the drug from the market (FDA News. July 13, 2005; FDC Reports – “The Pink Sheet” July 18, 2005; 67:3).

A once-daily extended-release (ER) oral formulation of the opioid analgesic hydromorphone hydrochloride (Palladone - Purdue Pharma) has been approved by the FDA for treatment of opioid-tolerant patients with persistent moderate to severe pain. Hydromorphone HCl, a semisynthetic congener of morphine and active metabolite of hydrocodone that has been used since the 1920s, is also available in immediate-release oral, injectable and suppository forms (Dilaudid, and others).