FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain

/PRNewswire/ -- Millions of Americans with moderate to severe acute pain and their health-care providers will soon have a new treatment option. Today, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (J&JPRD), announced that the U.S. Food and Drug Administration (FDA) approved tapentadol immediate-release tablets for the relief of moderate to severe acute pain in adults 18 years of age or older.

Tapentadol is a new centrally acting oral analgesic. It has two mechanisms of action, combining mu-opioid receptor agonism and norepinephrine reuptake inhibition.

Tapentadol tablets have been approved in 50 mg, 75 mg and 100 mg doses.

The approval was based on data from clinical studies involving more than 2,100 patients. The studies, which were presented at the 27th Annual Scientific Meeting of the American Pain Society earlier this year, showed that tapentadol provided significant relief of moderate to severe acute pain compared to placebo.

Following today's FDA approval, and as per Federal regulation for all controlled substances, tapentadol will be reviewed by the U.S. Drug Enforcement Agency for scheduling, and it cannot be sold until it receives a scheduling classification.

A trade name for tapentadol has not yet been determined.

"We are pleased with the FDA's approval today. Tapentadol represents a new treatment option in pain management, and I am excited that we are able to bring this new choice to patients who are suffering from pain," said Joanne Waldstreicher, M.D., Global Head, Research and Development for CNS/Internal Medicine, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More than 25 million Americans experience acute pain each year as a result of injuries or surgery, and it is the most common reason people seek medical attention.

"We welcome new proven options that can help people with pain," said Mark Rasmussen, President/CEO, The National Pain Foundation, Denver, CO.

PriCara(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market tapentadol in the United States. J&JPRD and Ortho-McNeil-Janssen Pharmaceuticals, Inc. are wholly owned subsidiaries of Johnson & Johnson.

Approval Based on Results of Phase 3 Studies

Multiple Phase 3 studies presented at the 27th Annual Scientific Meeting of the American Pain Society in May showed tapentadol offers patients significant relief of their pain when compared to placebo, and that the medicine was generally well tolerated in these studies.

The studies were conducted in different patient groups, including those who had a bunionectomy, a standard foot surgery associated with predictable levels of moderate to severe pain, and in those with pain from end-stage joint disease.

At the same meeting, a Phase 3 safety study of tapentadol immediate-release tablets was presented. This study evaluated tapentadol in patients with low back pain or pain from osteoarthritis of the hip or knee. It demonstrated that tapentadol offers pain relief and is generally well tolerated. (http://www.jnj.com/connect/news/all/20080509_160001)

Two Mechanisms of Action

Mu-opioid agonists are drugs that bind to and activate mu-opioid receptors in the central nervous system. These drugs modify sensory and affective aspects of pain, inhibit the transmission of pain at the spinal cord and affect activity at parts of the brain that control how pain is perceived. Norepinephrine reuptake inhibitors are a type of central nervous system medication that increases the level of norepinephrine in the brain by inhibiting its re-absorption into nerve cells; these compounds have analgesic properties.

IMPORTANT SAFETY INFORMATION

Tapentadol is contraindicated in any situation where mu-opioid agonists are contraindicated (i.e., significant respiratory depression, acute or severe bronchial asthma or hypercapnia); in patients with paralytic ileus; or in patients currently using or within 14 days of using monoamine oxidase inhibitors (MAOI).

Due to its mu-opioid receptor agonism, respiratory depression is a possible adverse event of tapentadol. Tapentadol should be administered with caution to the elderly, debilitated patients, and patients with conditions accompanied by hypoxia, hypercapnia or decreased respiratory reserve such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, CNS depression, or coma. Patients receiving other mu-opioid agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol, opioids or illicit drugs) concomitantly with tapentadol may exhibit an additive CNS depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, or coma may result if these drugs are taken in combination with tapentadol. When such combined therapy is contemplated, a dose reduction of one or both agents should be considered.

Like other drugs with mu-opioid agonist activity, tapentadol should not be used in patients susceptible to increased intracranial pressure, impaired consciousness, or coma. It should be used with caution in patients with head injury, intracranial lesions, or other sources of preexisting increased intracranial pressure. Tapentadol should be used with caution in patients with pancreatic or biliary tract disease, and moderate hepatic impairment. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses.

Tapentadol can be abused in a manner similar to other mu-opioid agonists, legal or illicit. This should be considered when prescribing or dispensing tapentadol in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Abuse of tapentadol poses a risk of overdose and death. This risk is increased with concurrent abuse of tapentadol with alcohol and other substances. Monitor patients closely for signs of abuse and addiction.

Tapentadol may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Tapentadol should be prescribed with care in patients with a history of a seizure disorder or any condition that would put the patient at risk of seizures.

The development of a potentially life-threatening serotonin syndrome may occur with use of SNRI products, including tapentadol, particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs and triptans, and with drugs which impair metabolism of serotonin (including MAOIs).

The most common adverse events (greater than or equal to 10% in any tapentadol dose group) in clinical trials were nausea, dizziness, vomiting, somnolence and headache.

For information about the package insert for tapentadol, consult the FDA Web site.

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Johnson & Johnson-Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall of Infants' MYLICON(R) GAS RELIEF DYE FREE Drops

Johnson & Johnson-Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall of Infants' MYLICON(R) GAS RELIEF DYE FREE Drops (Simethicone-Antigas) Non-Staining Due to Possible Metal Fragments

PRNewswire/ -- Johnson & Johnson-Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON(R) GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.

The two lots of Infants' MYLICON(R) GAS RELIEF DYE FREE drops non-staining 1 oz. bottles included in the recall are:

Product
Code # Lot # Exp Product
71683791111-1 SMF007 09/10 Infants' Mylicon(R) Gas Relief Dye Free
Non-Staining Drops 1 oz.

71683791111-1 SMF008 09/10 Infants' Mylicon(R) Gas Relief Dye Free
Non-Staining Drops 1 oz.

Consumers can find the lot numbers on the bottom of the box containing the product and also on the lower left side of the sticker on the product bottle.

Consumers who purchased Infants' MYLICON(R) GAS RELIEF DYE FREE drops non-staining included in this recall should immediately stop using the product and contact the company at 1-800-222-9435 (Monday -- Friday, 8:00 a.m. -- 8:00 p.m. EST) or via the internet at http://www.mylicon.com/ for instructions regarding how to dispose of the product and request a replacement or refund.

Infants' MYLICON(R) drops are sold over-the counter, in retail stores and pharmacies, as an anti-gas medicine to relieve the discomfort of infant gas frequently caused by air swallowing or by certain formulas or foods.

The recall does not affect any Original Infants' MYLICON(R) GAS RELIEF products (1/2 oz. or 1 oz. size) or Infants' MYLICON(R) GAS RELIEF DYE FREE drops non-staining (1/2 oz. size).

The manufacturer has instructed retailers and wholesalers to return their inventories.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm

Regular Mail: Use postage-paid FDA form 3500 available at:
http://www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD
20852-9787

Fax: 1-800-FDA-0178

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