Tampa, FL (May 9, 2008) – Many foot-surgery patients experience intense pain for several days following removal of a bunion, one of the most common foot surgeries. The investigational pain medication tapentadol provided significant relief for patients who had this surgery, compared to those treated with placebo. Treatment with tapentadol also resulted in patients reporting fewer gastrointestinal side effects compared to those treated with an older, prescription pain reliever, researchers announced today.
Results from a Phase 3 clinical study of tapentadol immediate release (IR) tablets, a novel, investigational, centrally acting oral analgesic, showed that patients receiving 50 mg, 75 mg, or 100 mg of the medication experienced significant relief in acute pain after bunionectomy, a standard foot surgery associated with predictable levels of moderate to severe pain.
The overall difference in the intensity of pain experienced by patients recovering from bunionectomy was examined over the first 12, 24, 48 and 72 hours after initiating treatment with tapentadol. All tapentadol IR treatment groups showed a statistically significant improvement in pain over patients who received placebo, over all of these time periods (P<0.001).
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) presented these new data in a poster session at the 27th Annual Scientific Meeting of the American Pain Society (APS) in Tampa, Florida.
Treatment with 100 mg of tapentadol IR resulted in 79 percent of patients experiencing at least a 30 percent improvement in pain intensity at 48 hours. This is comparable to the 78 percent of patients who experienced the same percentage of improvement with 15 mg of oxycodone IR. Compared with placebo, the incidence of adverse events was higher for tapentadol IR and oxycodone IR treatment groups with a dose-dependent pattern of increasing adverse events. The most common treatment emergent adverse events in both active treatment groups included nausea, vomiting, constipation, dizziness, and somnolence (drowsiness).
However, the overall incidence of gastrointestinal side effects was lower at all three tapentadol IR doses than with 15 mg of oxycodone IR: tapentadol IR 50 mg at 46 percent, 75 mg at 46 percent, and 100 mg at 59 percent versus oxycodone IR 15 mg at 73 percent.
“This Phase 3 study has shown that all three doses of tapentadol IR were effective in providing analgesic relief of moderate to severe pain. Tapentadol patients reported a reduced incidence of some gastrointestinal side effects in comparison with a comparable dose of oxycodone, a standard pain treatment,” said lead study author Charles Oh, M.D., Director, J&JPRD. “We are encouraged by these results and are eager to continue to study tapentadol as a novel acute pain treatment option.”
Tapentadol has a unique profile with two mechanisms of action, combining mu-opioid receptor agonism and norepinephrine reuptake inhibition in a single molecule. It is being developed in immediate-release formulation for acute pain and extended-release formulation for chronic pain.
Acute pain is viewed as a complex, unpleasant experience with emotional and cognitive, as well as sensory features that occur in response to tissue trauma and is one of the most common reasons why patients seek medical attention. Common sources of acute pain include trauma, surgery, labor, medical procedures, and acute disease states. According to the American Pain Foundation, more than 25 million Americans experience acute pain each year as a result of injuries or surgeries.
The use of tapentadol IR for the treatment of moderate to severe acute pain is under review by the United States Food and Drug Administration. The New Drug Application (NDA) was filed on January 23, 2008. Upon FDA approval, PriCara™, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market tapentadol in the United States. The NDA filing is part of the ongoing commitment of J&JPRD and PriCara™ to bring new and innovative products to patients and physicians for the treatment and management of pain.
This Phase 3, double-blind, randomized, multi-center trial examined the efficacy, safety and tolerability of multiple doses of tapentadol IR in 603 post-surgical bunionectomy patients. Participants were randomly assigned (1:1:1:1:1) to receive tapentadol IR 50, 75, or 100 mg, oxycodone 15 mg, or placebo and the primary efficacy endpoint was the sum of their pain intensity differences at 48 hours. Secondary endpoints included sum of pain intensity differences at 12, 24, and 72 hours.
J&JPRD and Grünenthal GmbH supported this study.
J&JPRD and Ortho-McNeil-Janssen Pharmaceuticals, Inc. are wholly owned subsidiaries of Johnson & Johnson.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (J&JPRD) is a wholly owned subsidiary of Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout Europe, the United States and Asia. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas, including CNS, Internal Medicine and Oncology, to address unmet medical needs worldwide. More information can be found at http://www.jnjpharmarnd.com/.
PriCara™, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
PriCara™, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is a major health care company in the United States dedicated to the needs of primary care providers who serve a vital role on the frontline of medicine. For more information about the company, please visit www.PriCara.com.
Grünenthal, a privately owned pharmaceutical company based in Aachen, Germany, discovered and started development of tapentadol. Grünenthal and J&JPRD have shared development responsibilities for tapentadol for acute and chronic pain conditions since the companies signed a licensing agreement for tapentadol in 2003.
Grünenthal licensed marketing rights to tapentadol to Ortho-McNeil-Janssen Pharmaceuticals, Inc. for the United States, Canada and Japan. Grünenthal maintains marketing rights in Europe and other parts of the world. A trade name for the product has not yet been determined.
[This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of the Company's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov <http://www.sec.gov>, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.]