FDA OKs the Pain Drug Opana
Prescription Drug Is Oral Form of Painkiller That Used to Be Injection-Only
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
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.
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
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.
Like other opioids, Opana and Opana ER can be abused, warns Endo
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.