Endo Pharmaceuticals Inc., a wholly owned subsidiary Endo Pharmaceuticals Holdings Inc, has announced the commercial availability of Opana ER and Opana tablets. Endo has begun shipments to its customers and is instituting a wholesale and retail stocking programme, to ensure these products, are distributed to retail pharmacies across the US over the next several weeks. Opana ER and Opana are extended-release and immediate-release formulations of oxymorphone hydrochloride (HCl), which were approved by the US Food and Drug Administration on June 22, 2006.
A new oral extended-release opioid analgesic treatment option for patients, 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. Opana ER 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 and 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 Opana ER and Opana are available by prescription only.
This fall, Endo also plans to re-launch its injectable formulation of oxymorphone in the hospital setting under the new trade name. This will complete the "continuum of care" for Opana by making it available in parenteral, short- and long- acting oral formulations.
"We are delighted to be able to provide physicians and patients with this new, much-needed option for patients with moderate-to-severe pain, and particularly for patients who have not found satisfaction with their current opioid treatment," stated Peter A. Lankau, President and CEO, "As a leader in pain management, we also take very seriously our responsibility of helping physicians and caregivers appropriately manage pain. We are confident that Endo's Promise initiative, combined with our Risk Minimization Action Plan developed in conjunction with the FDA and other outside experts, will effectively minimize the inherent risks of opioid misuse, abuse and diversion through comprehensive education and support programs for both patients and physicians."
Opana ER and Opana tablets were formulated using oxymorphone hydrochloride, a semisynthetic, pure microgram-opioid agonist, that had been available previously only as an injectable formulation. Both products have been proven to achieve effective relief in multiple moderate-to-severe pain models, in opioid-naive and opioid-experienced patients.