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news.The FDA has granted approval for Endo Pharmaceuticals to market its extended-release opioid analgesics Opana and Opana ER.
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The newly approved products are the extended-release (ER) and immediate-release formulations of oxymorphone hydrochloride.
Opana ER is indicated for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time and is not intended to be used on an as-needed basis. This is the first time oxymorphone will be available in an oral, extended-release formulation. Opana ER will be available in 5mg, 10mg, 20mg and 40mg tablets.
Opana (the immediate-release version) is indicated for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate and will be available in 5mg and 10mg tablets. Both products are expected to be commercially available in the US in the coming weeks.
Endo also plans to re-launch its oxymorphone hydrochloride injection under the new trade name in the hospital setting.
“The clinical program for Opana ER and Opana represents one of the most comprehensive ever conducted for an opioid analgesic, with more than 15 clinical trials enrolling over 3,000 patients,” said Peter Lankau, president and CEO of Endo.