FDA approves extended-release hydromorphone for pain.(Clinical Rounds)

The approval of an extended-release formulation of the potent opioid agonist hydromorphone was accompanied by a risk management plan aimed at reducing abuse and minimizing diversion of the drug, a notorious problem with the controlled-release opioid agonist oxycodone.

The Food and Drug Administration approved extended-release hydromorphone for "the management of persistent moderate to severe pain in patients requiring continuous around-the-clock analgesia with a high potency opioid for an extended period of time," generally lasting "weeks to months or longer."

The new agent, marketed as Palladone, is expected to become available sometime during the first half of 2005; but for the first 18 months on the market, it will only be marketed to a limited number of health professionals experienced in prescribing opioid analgesics, according to Purdue Pharma, the Stamford, Conn.-based company that also manufactures oxycodone under the trade name OxyContin.

Purdue worked with the FDA to develop a Risk Management Program (RMP) that is intended to facilitate proper patient selection, reduce abuse, minimize diversion, and avoid pediatric exposure and other improper uses of the opioid, according to a Purdue Pharma statement that announced the approval.

Elements of the plan include extensively educating prescribers, caregivers, and patients.

In addition, a program will be established to monitor utilization, with interventions in place if abuse, misuse, and diversion of the drug are identified.

A medication guide containing FDA-approved information for patients will also be required to be dispensed with each prescription. Guides generally are required by the FDA when, for example, patient labeling could help prevent serious adverse effects.