RARITAN, N.J., Dec. 1 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for 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.
Tapentadol ER is a novel 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.
Data from these studies provide evidence that tapentadol ER has efficacy to reduce moderate to severe chronic pain compared to placebo. The data also provide evidence of long-term safety and tolerability of tapentadol ER.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (J&JPRD) is conducting the clinical program for tapentadol in the United States. J&JPRD submitted the NDA for tapentadol on behalf of Ortho-McNeil-Janssen Pharmaceuticals, Inc., an affiliated company that will hold the NDA for tapentadol. Upon FDA approval, PriCara,(R) Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market tapentadol ER in the United States.
NUCYNTA(TM) (tapentadol) CII immediate release tablet formulation is approved by the FDA 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(TM) (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(TM) 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(TM) may increase airway resistance and decrease respiratory drive to the point of apnea. Alternative non-mu-opioid agonist analgesics should be considered and NUCYNTA(TM) 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(TM) 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(TM) should be used with caution in patients with head injury, intracranial lesions, or other sources of preexisting increased intracranial pressure.
Experience with NUCYNTA(TM) 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(TM) 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(TM) has not been systematically evaluated in patients with a seizure disorder, and such patients were excluded from clinical studies. NUCYNTA(TM) 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(TM) 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(TM).
NUCYNTA(TM) is not recommended in patients with severe renal or hepatic impairment. NUCYNTA(TM) should be used with caution in patients with moderate hepatic impairment. Like other drugs with mu-opioid agonist activity, NUCYNTA(TM) may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis.
To see the NUCYNTA(TM) full prescribing information, go to http://www.pricara.com/pricara/pages/products_list.jsp or www.NUCYNTA.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.
[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.]
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