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).

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).

The FDA has approved the opioid agonist hydromorphone in a once-daily extended-release (ER) oral tablet formulation (Exalgo – Covidien) for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, long-term therapy. Another hydromorphone ER formulation (Palladone – Purdue) was available previously, but was withdrawn from the market because taking it with alcohol could interfere with the extended-release mechanism and lead to rapid release of potentially lethal amounts of the drug ("dose-dumping").