New extended-release opioid treats persistent pain

October 25, 2004

Tens of millions of people in the United States are affected by pain, which is associated with a variety of effects that can destroy the pain sufferer's quality of life. Treating and controlling pain is a primary concern for all members of a healthcare team. Despite the attention given to the association of opioids with drug abuse, consensus statements from experts support the use of these products to treat chronic pain. And soon a new opioid will be available for sufferers of chronic, persistent pain.

Tens of millions of people in the United States are affected by pain, which is associated with a variety of effects that can destroy the pain sufferer's quality of life. Treating and controlling pain is a primary concern for all members of a healthcare team. Despite the attention given to the association of opioids with drug abuse, consensus statements from experts support the use of these products to treat chronic pain. And soon a new opioid will be available for sufferers of chronic, persistent pain.

Palladone (hydromorphone HCl extended-release) capsules, developed by Purdue Pharma, have been approved for the management of persistent, moderate to severe pain in patients requir-ing continuous 24-hour analgesia over extended periods of time. This is the first long-acting hydromorphone formulation to receive Food & Drug Administration approval.

The Schedule II product "may be a useful therapy for patients taking short-acting opioids whose pain is not well controlled or who may benefit from once-daily dosing," noted Sharon Weinstein, M.D., a lead clinical investigator and associate professor of anesthesiology, neurology, and oncology at the University of Utah in Salt Lake City.

Based on the risks associated with the drug, including its abuse potential, Purdue worked closely with the FDA to develop a comprehensive risk management program (RMP). For the first 18 months following the launch of Palladone, Purdue will limit its promotion to a limited number of physicians, focusing on those experienced in prescribing opioid analgesics. As part of the RMP, a patient's medication guide is to be dispensed with each prescription. "The goal is to ensure safe use of the medication," said J. David Haddox, VP for health policy at Purdue. "We're trying to optimize the benefit-risk ratio for this drug."

The labeling also carries a tough black-box warning that the drug should be used "only in patients receiving opioid therapy who have demonstrated opioid tolerance and who require a minimum total daily dose of opiate medication equivalent to 12 mg of oral hydromorphone."

"Opioid-tolerance doesn't refer to tolerance to analgesia but tolerance to the respiratory effects of opioids," explained Lipman. Their use in non-opioid-tolerant patients may lead to fatal respiratory depression. "It is important for pharmacists to read the label, be aware of what is in the boxed warning, and counsel patients on appropriate use," he added.

The efficacy of Palladone was established in a double-blind, randomized, placebo-controlled four-week trial of patients aged 18 and over with pain that was present for at least one month. Patients randomized to Palladone maintained adequate analgesia for a significantly longer period of time than patients randomized to placebo. The most common adverse events reported were constipation, nausea, infection, headache, and somnolence.

Palladone is expected to be available in pharmacies in the first half of 2005. It will be marketed in 12-, 16-, 24-, and 32-mg dosage strengths.