FDA OKs the Pain Drug Opana

Prescription Drug Is Oral Form of Painkiller That Used to Be Injection-Only

Medically Reviewed by Louise Chang, MD on June 23, 2006
From the WebMD Archives

June 23, 2006 -- The FDA has approved a new prescription drug to ease moderate to severe pain.

The drug, called Opana, is an opioid pain reliever taken by mouth. It will come in an extended-release form, called Opana ER, and an immediate-release version, simply called Opana.

"Both products are expected to be commercially available in the U.S. in the coming weeks," states Opana's maker, Endo Pharmaceuticals, in a news release.

The drugs contain oxymorphone hydrochloride, which was previously only available by injection. Endo Pharmaceuticals plans to relaunch the drug's injected version for hospital use under the new trade name.

Extended Release vs. Immediate Release

Opana and Opana ER have different uses.

Opana ER -- the first oral, extended-release version of oxymorphone -- is intended for patients with moderate to severe pain who need "continuous, around-the-clock opioid treatment for an extended period of time," states Endo Pharmaceuticals. Opana ER "is not intended to be used on an as-needed basis," the drug company notes.

Immediate-release Opana is for "moderate to severe acute pain where the use of an opioid is appropriate," states Endo Pharmaceuticals.

Opana ER tablets will come in four doses: 5 milligrams, 10 milligrams, 20 milligrams, and 40 milligrams. Opana's immediate-release tablets will come in two doses: 5 milligrams and 10 milligrams.

Drug's Trials

Fifteen clinical trials of Opana and Opana ER have included more than 3,000 patients. Two of those trials are described in Endo Pharmaceuticals' news release.

In one trial, patients with moderate to severe low back pain took Opana ER or a tablet lacking medicine (placebo) for 12 weeks without knowing which pill was which. Patients taking Opana ER had a greater drop in average pain intensity than those in the placebo group.

In another trial, patients with moderate to severe pain after abdominal surgery received immediate-release Opana or a placebo without knowing which pill they'd gotten. The Opana group took their tablets for less time than those in the placebo group.

Opana's Warnings

Like other opioids, Opana and Opana ER can be abused, warns Endo Pharmaceuticals.

In addition, "patients must not consume alcoholic beverages, or prescription or nonprescription medications containing alcohol, while on Opana ER therapy" due to possible overdose risk, the drug company notes.

According to Endo Pharmaceuticals, the most common adverse effects seen in clinical trials of Opana ER were nausea, constipation, dizziness, vomiting, itchiness, sleepiness, headache, increased sweating, and sedation. The most common adverse effects seen in clinical trials of immediate-release Opana were nausea and fever.

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SOURCES: News release, FDA. News release, Endo Pharmaceuticals.

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