New opioid formulation fits nicely into rotation

August 21, 2006

The Food & Drug Administration recently granted marketing approval to oxymorphone immediate-release and oxymorphone extended-release tablets (Opana/Opana ER, Endo Pharmaceuticals).

Opana is approved for relief of moderate to severe acute pain where the use of an opioid is appropriate. Opana ER is approved for relief of moderate to severe pain in patients requiring round-the-clock opioid treatment for an extended period. This approval marks the first time oxymorphone will be available in an oral, extended-release formulation. Opana ER will be available in retail pharmacies during the next several weeks.

The recommended starting dose of Opana in opioid-naïve patients is 10 mg to 20 mg every four to six hours. The manufacturer does not recommend initiating therapy with Opana at doses higher than 20 mg. The recommended starting dose of Opana ER in opioid-naïve patients is 5 mg every 12 hours. Thereafter, it is recommended that the dose be titrated, in increments of 5 mg to 10 mg every 12 hours at three-to seven-day intervals.

Those receiving Opana may be converted to Opana ER by administering half of their total daily Opana dose as Opana ER every 12 hours, according to Endo. The maker also advised that those receiving parenteral oxymorphone may be converted to Opana by administering 10 times the total daily parenteral oxymorphone dose as Opana, in four to six equally divided doses. Those receiving parenteral oxymorphone may be converted to Opana ER by administering 10 times the total daily parenteral oxymorphone dose as Opana ER, in two equally divided doses. To convert from other oral opioids to Opana or Opana ER, Endo advises healthcare professionals to refer to published relative-potency information.

Mary Lynn McPherson, Pharm.D., a professor of pharmacy at the University of Maryland School of Pharmacy in Baltimore, said that according to the manufacturer, the conversion ratio for oxymorphone : morphine is 10 mg : 30 mg. Opana ER should be prescribed as a standing order of every 12 hours, and should not be used on an as-needed basis. Older adults should start Opana and Opana ER therapy at very low doses. "Opana and Opana ER should be taken on an empty stomach," she said. "Do not drink alcohol while taking either product."

Opana will be available in 5-and 10-mg tablets; Opana ER will be available in 5-, 10-, 20-, and 40-mg tablets. Endo plans to relaunch its injectable formulation of oxymorphone in the hospital setting under the Opana name.

So that opioids can be responsibly prescribed to patients, Endo has set up a Partnership for Responsible Opioid Management through Information, Support, and Education (PROMISE) program. More information can be found at http://www.endopromise.com/.

THE AUTHOR is a writer based in New Jersey.