Safety and Efficacy Data from Phase 3 Study will be Highlighted
SAN DIEGO, May 7 /PRNewswire-USNewswire/ -- Chronic pain is a significant medical challenge in the United States, and chronic low back pain is the most common cause of disability in developed countries. An estimated 100 million Americans suffer from chronic pain each year. If left undertreated, chronic pain can impair an individual's ability to carry out daily activities and diminish quality of life.
Three clinical presentations about the use of tapentadol extended release tablets to treat patients with chronic low back pain, including pivotal Phase 3 safety, efficacy and gastrointestinal tolerability data, will be discussed during the poster sessions of the 28th Annual Scientific Meeting of the American Pain Society (APS) in San Diego, California on Thursday, May 7, and Friday, May 8, 2009. These data presentations are supported by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD).
Tapentadol binds to mu-opioid receptors and inhibits norepinephrine re-uptake. Although the exact mechanism of action is not known, these two mechanisms, which affect established pain pathways, are thought to be responsible for pain relief with tapentadol. The U.S. Drug Enforcement Agency has proposed placing the tapentadol molecule into Schedule II of the Controlled Substances Act.
J&JPRD continues to study tapentadol extended release formulation for chronic pain, and a New Drug Application (NDA) is planned for submission to the United States Food and Drug Administration (FDA) this year. The NDA filing is part of the ongoing commitment of J&JPRD and PriCara(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., to bring new and innovative products to patients and physicians for the treatment and management of pain.
The following posters on tapentadol extended release data will be presented at the 2009 APS meeting:
Thursday, May 7: 4:15-5:45 PM
Poster 301: Efficacy and Safety of Tapentadol ER for Chronic Low Back Pain: Results of a Randomized, Double-blind, Placebo- and Active-controlled Phase 3 Study; Primary investigator: Robert Buynak, M.D.
Poster 293: Efficacy, Safety, and Gastrointestinal Tolerability of Tapentadol ER in a Randomized, Double-blind, Placebo- and Active-controlled Phase III Study of Patients With Chronic Low Back Pain; Primary investigator: Robert Buynak, M.D.
Friday, May 8: 4:00-5:30 PM
Poster 306: A Randomized, Double-blind, Placebo- and Active-controlled Phase 3 Study of Tapentadol ER for Chronic Low Back Pain: Analysis of Efficacy Endpoint Sensitivity; Primary investigator: Mila Etropolski, M.D.
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(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
PriCara(R), 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.
Grunenthal, a privately owned pharmaceutical company based in Aachen, Germany, discovered and started development of tapentadol. Grunenthal 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. Grunenthal licensed marketing rights to tapentadol to Ortho-McNeil-Janssen Pharmaceuticals, Inc. for the United States, Canada and Japan. Grunenthal maintains marketing rights in Europe and other parts of the world.
[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 Pharmaceutical Research & Development, L.L.C. and/or 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 Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 28, 2008. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Johnson & Johnson Pharmaceutical Research & Development, L.L.C. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.]
CONTACT: Greg Panico of Johnson & Johnson Pharmaceutical Research &
Development, L.L.C., +1-908-240-2011, +1-908-927-3715
Web site: http://www.jnjpharmarnd.com//