New opioid formulation fits nicely into rotation
Aug 21, 2006
By: Charlotte LoBuono
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.
"Opana ER represents a new member in a group of long-acting opioids now considered the standard of care for the treatment of chronic, non-cancer pain," said Russell Portenoy, M.D., chairman, Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York City. "The immediate-release formulations are often used to treat breakthrough pain in combination with a long-acting opioid.
"This approval makes available an opioid not used previously for the management of chronic pain," said Portenoy. Individuals respond differently to each of the opioid analgesics, and we may need to rotate opioids in order to identify the compound that produces the most favorable ratio of analgesia to adverse effect, he said. "We can easily incorporate oral oxymorphone into this process of opioid rotation." The adverse-effect profiles of Opana and Opana ER are comparable to those of other opioids, he said.
The recommended starting dose of Opana in opioid-naive 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 www.endopromise.com/.
THE AUTHOR is a writer based in New Jersey.
Opana含有适量的阿片类物质，用于缓解中、重度疼痛。Opana ER（控释制剂）是一种缓解中、重度疼痛长达12小时的阿片类制剂，也是第一个被批准的羟吗啡酮的口服缓释制剂。Opana ER在几周内将会在药店零售。
“Opana ER作为长效阿片类药物中的一个新药，目前已经被确认为治疗慢性、非癌症疼痛的标准治疗药物。”纽约市贝斯以色列医学中心疼痛药物及治疗科主任——医学博士Russell Portenoy如是说。“而其速释制剂用于突发性疼痛，与长效阿片类制剂合并使用。”
Portenoy说：“这种药物治疗慢性疼痛不用预先服用。”每种阿片类止痛药都会产生个体差异，我们采用反转阿片类物质是为了达到最好的无痛治疗状态，而尽量降低不良反应。（也就是达到无痛和无不良反应最好的平衡点）“口服羟吗啡酮更便于与反转阿片类物质合并使用。” Opana and Opana ER的不良反应与其他同类阿片类药物基本相近。
作者:admin@医学,生命科学 2011-09-18 05:12