Endo says Opana now commercially available to treat pain

By E. Janene Geiss

Philadelphia, July 24 - Endo Pharmaceuticals Inc. announced Monday the commercial availability of Opana ER and Opana tablets.

Endo said it has begun shipments to its customers and is instituting a wholesale and retail stocking program to ensure these products are distributed to retail pharmacies across the United States over the next several weeks, according to a company news release.

Opana ER and Opana are extended-release and immediate-release formulations of oxymorphone hydrochloride (Hcl) that were approved by the Food and Drug Administration on June 22.

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 5 mg, 10 mg, 20 mg and 40 mg 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 5 mg and 10 mg tablets.

Both Opana ER and Opana are available by prescription only.

This fall, Endo said it also plans to relaunch 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, officials said.

Endo said it has made a commitment to responsible pain management through a program called Promise, which offers support programs to better ensure the appropriate and responsible use of opiods.

Through extensive experience with opioid analgesics and working with the FDA and industry experts, Endo said it has developed a comprehensive risk minimization action plan for Opana ER and Opana.

The Promise program evolved from the risk minimization plan. It stands for the Partnership for Responsible Opioid Management through Information, Support and Education.

The Promise initiative contains essential information and guidance to health care professionals so that they can prescribe opioids to patients responsibly and appropriately.

A wholly owned subsidiary of Chadds Ford, Pa.-based Endo Pharmaceuticals Holdings Inc., Endo Pharmaceuticals Inc. is a specialty pharmaceutical company.

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