Study Suggests that ULTRACET(TM) (37.5 mg tramadol/325 mg of acetaminophen) Provides Rapid Relief of Oral Surgery Pain


SAN DIEGO, March 11 /PRNewswire/ -- Data presented here at the International and American Association of Dental Research suggest that ULTRACET, a recently approved analgesic, rapidly relieves pain associated with oral surgery with a sustained duration. In addition, ULTRACET worked as well as high dose hydrocodone/acetaminophen, a standard treatment for dental pain, but with less nausea and vomiting.

This study, which was sponsored by the maker of ULTRACET, Ortho-McNeil Pharmaceuticals, Inc., further supports that ULTRACET is an excellent treatment option for patients who experience acute pain following dental surgery.

"Oral surgeons are always looking for effective analgesics to use," said James R. Fricke, Jr., DDS, MSD of the PPD Dental Pain Research Center in Austin, TX. "This study firmly supports ULTRACET as a welcome addition to our analgesia armamentarium."

This study, involving 200 patients, was conducted at the PPD Dental Pain Research Center in Austin, TX. It was a randomized, double-blind, placebo- and active-controlled, single-dose study in patients experiencing moderate-to-severe dental pain following oral surgery. Patients were randomized to receive one or two tablets of ULTRACET, a tablet of 10 mg hydrocodone/650 mg acetaminophen or placebo. Pain intensity and relief were measured 30 minutes and then hourly for eight hours.

According to the data, ULTRACET provided rapid pain relief compared to placebo. Two ULTRACET tablets provided comparable pain relief over eight hours to hydrocodone/acetaminophen. Regardless of the dose of ULTRACET, patients reported 50 percent less nausea and vomiting, a common side effect of many analgesics.

In this study, ULTRACET, a non-scheduled opioid drug, was generally well tolerated. The most commonly reported adverse events in the study in patients receiving ULTRACET were dizziness, nausea and vomiting. There were no serious adverse events reported in this trial.

ULTRACET was approved in August 2001 by the U.S. Food and Drug Administration for the short-term (five days or less) management of acute pain. In clinical trials, two ULTRACET tablets provided greater pain relief and reduced pain intensity better than ULTRAM(R) (tramadol) given at the same dose. ULTRACET delivers fast onset and long-lasting pain relief for acute conditions such as sprains, strains, joint pain flares and postoperative pain.

ULTRACET is contraindicated in any situation where opioids are contraindicated. Seizures have been reported in patients receiving tramadol.

The risk of seizures is increased with doses of tramadol above the recommended range. Tramadol increases the seizure risk in patients taking certain medications (e.g., tricyclic antidepressants, SSRIs, opioids). Tramadol may enhance the seizure risk in patients taking MAO inhibitors, neuroleptics, or other drugs that reduce the seizure threshold or in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections). See WARNINGS in full prescribing information.

Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive ULTRACET. ULTRACET should not be used concomitantly with alcohol consumption. The use of ULTRACET in patients with liver disease is not recommended. Withdrawal symptoms may occur if ULTRACET is discontinued abruptly. ULTRACET should not be used concomitantly with other acetaminophen-containing products.

Tramadol may induce psychic and physical dependence of the morphine type (mu-opioid). Cases of abuse and dependence on tramadol have been reported. Tramadol should not be used in opioid-dependent patients. Since tramadol can reinitiate physical dependence, ULTRACET is not recommended for patients with a tendency to drug abuse, a history of drug dependence, or chronically using opioids.

The most frequently reported side effects experienced with ULTRACET were constipation, somnolence, and sweating.

Please see full prescribing information for more information on Warnings, Precautions and additional Adverse Reactions that may occur, regardless of drug relationship. For more information about ULTRACET, visit the website at www.ULTRACET.com., or Ortho-McNeil Pharmaceutical, visit www.orthomcneil.com.
Ortho-McNeil Pharmaceutical manufactures and markets prescription pharmaceutical products in several therapeutic categories including analgesics, infectious diseases, women's health, central nervous system and wound healing.

Note: Full prescribing Information for ULTRACET is available by calling 1-800-682-6532 or by visiting www.ULTRACET.com.