SAN ANTONIO, Feb. 4 /PRNewswire/ -- 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.
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.
The NDA filing is part of the ongoing commitment of J&JPRD and PriCara(R) to bring new and innovative products to patients and physicians for the treatment and management of pain.
NUCYNTA(R) (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.
IMPORTANT SAFETY INFORMATION FOR NUCYNTA(R) (tapentadol) CII IMMEDIATE RELEASE TABLET FORMULATION
Respiratory depression is the primary risk of mu-opioid agonists. Respiratory depression occurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation. NUCYNTA(R) 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. In such patients, even usual therapeutic doses of NUCYNTA(R) may increase airway resistance and decrease respiratory drive to the point of apnea. Alternative non-mu-opioid agonist analgesics should be considered and NUCYNTA(R) should be employed only under careful medical supervision at the lowest effective dose in such patients. If respiratory depression occurs, it should be treated as any mu-opioid agonist-induced respiratory depression.
Opioid analgesics can raise cerebrospinal fluid pressure as a result of respiratory depression with carbon dioxide retention. Therefore, NUCYNTA(R) should not be used in patients susceptible to the effects of raised cerebrospinal fluid pressure such as those with head injury and increased intracranial pressure. Opioid analgesics may obscure the clinical course of patients with head injury due to effects on pupillary response and consciousness. NUCYNTA(R) should be used with caution in patients with head injury, intracranial lesions, or other sources of preexisting increased intracranial pressure.
Experience with NUCYNTA(R) overdose is very limited. Management of overdose should be focused on treating symptoms of mu-opioid agonism. Primary attention should be given to reestablishment of a patent airway and institution of assisted or controlled ventilation when overdose of NUCYNTA(R) is suspected. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.
NUCYNTA(R) has not been systematically evaluated in patients with a seizure disorder, and such patients were excluded from clinical studies. NUCYNTA(R) 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.
Withdrawal symptoms may occur if NUCYNTA(R) is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely, hallucinations. Withdrawal symptoms may be reduced by tapering NUCYNTA(R).
NUCYNTA(R) is not recommended in patients with severe renal or hepatic impairment. NUCYNTA(R) should be used with caution in patients with moderate hepatic impairment. Like other drugs with mu-opioid agonist activity, NUCYNTA(R) may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis.
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 www.jnjpharmarnd.com.
Grunenthal
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.
CONTACT: Srikant Ramaswami (Media inquiries), +1-609-647-8195, or Lesley
Fishman (Investor Relations inquiries) +1-732-524-3922, for Johnson &
Johnson Pharmaceutical Research & Development, L.L.C.
Web site: http://www.jnjpharmarnd.com/
http://www.PriCara.com/
http://www.NUCYNTA.com/
