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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 easemoderate to severe pain.

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

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

The drugs contain oxymorphone hydrochloride, which was previously onlyavailable by injection. Endo Pharmaceuticals plans to relaunch the drug'sinjected 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 -- isintended for patients with moderate to severe pain who need "continuous,around-the-clock opioid treatment for an extended period of time," statesEndo Pharmaceuticals. Opana ER "is not intended to be used on an as-neededbasis," the drug company notes.

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

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

Drug's Trials

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

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

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

Opana's Warnings

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

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

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