Press Release

San Antonio, TX (February 4, 2010) – Data from three important studies on tapentadol extended release (ER) tablets, an investigational oral analgesic for the management of moderate to severe chronic pain in patients 18 years of age or older, will be discussed during the poster sessions of the 26th Annual Meeting of the American Academy of Pain Medicine (AAPM), February 3-6, 2010 in San Antonio, TX.

Following are details about the presentations, which are supported by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD).

WHAT:
Poster 166: Efficacy and Tolerability of Tapentadol Extended Release for Diabetic Peripheral Neuropathic Pain: Results of a Randomized-Withdrawal, Double-Blind, Placebo-Controlled Phase 3 Study. Lead author: Mila S. Etropolski, M.D.

Poster 125: Dose Stability of Tapentadol Extended Release for the Relief of Moderate to Severe Chronic Osteoarthritis Knee Pain. Lead author: Kathleen Kelly, M.D.

Poster 112: Dose Equivalence and Direct Conversion Between Tapentadol Immediate Release and Tapentadol Extended Release for Moderate to Severe Chronic Low Back Pain. Lead author: Mila S. Etropolski, M.D.



WHEN:
Wednesday, February 3 from 5:00 to 6:30 p.m. central time (CT) and Thursday, February 4 from 6:00 to 7:00 p.m. CT



WHERE:
Exhibit Hall B of the Henry B. Gonzalez Convention Center in San Antonio, TX

Tapentadol ER is an investigational, centrally acting oral analgesic that 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 tapentadol ER tablet formulation is designed to provide a high degree of mechanical resistance, such as to crushing or chewing.

J&JPRD announced on December 1, 2009 that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tapentadol extended release (ER) tablets for the management of moderate to severe chronic pain in patients 18 years of age or older. The NDA is currently under review. PriCara®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. will market tapentadol extended release tablets in the United States when the product is approved by the FDA.

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.

Chronic pain is a significant public health issue in the United States. According to the National Institutes of Health, an estimated 100 million Americans suffer from chronic or recurrent pain. If not treated effectively, chronic pain can impair an individual’s ability to carry out daily activities.

NUCYNTA® (tapentadol) CII immediate release tablet formulation was approved by the FDA on November 20, 2008 and is available by prescription only for the relief of moderate to severe acute pain in patients 18 years of age or older. The tapentadol molecule is classified as Schedule II of the Controlled Substances Act.

J&JPRD and Ortho-McNeil-Janssen Pharmaceuticals, Inc. are wholly owned subsidiaries of Johnson & Johnson.

For more information:
http://www.jnj.com/connect/news/all/20100204_090000

Last updated on: 27/08/2010 11:40:18