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| |  Once Daily Ultram ER Extended-Release Tablets Now Available in the United States New formulation provides option for patients who suffer from moderate to moderately severe chronic pain RARITAN, NJ, and TORONTO, CANADA -- February 21, 2006 -- A new prescription option is now available to the more than 50 million Americans who suffer from moderate to moderately severe chronic pain. Ortho-McNeil, Inc. and Biovail Corporation today announced that once-daily Ultram(R) ER (tramadol HCl) extended-release tablets are now available by prescription in the United States. Ultram ER is the first extended release tramadol product approved in the United States for relief of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. Ultram ER is available in once-daily dosage strengths of 100 mg, 200 mg and 300 mg tablets. The U. S. Food and Drug Administration (FDA) approved Ultram ER in September 2005 based on clinical and safety data obtained from four well- controlled clinical trials. More than 3,000 patients have been treated with Ultram ER in clinical trials. "Chronic pain affects a large segment of the U.S. population, with an estimated 45 percent of all Americans seeking care for persistent pain at least once during their lifetime," said Dr. Warren A. Katz, Clinical Professor of Medicine, University of Pennsylvania School of Medicine, Director of the Osteoporosis Center and Rheumatology at the Rothman Institute. "Ultram ER is an important new option for patients who suffer from moderate to moderately severe chronic pain, and for the physicians who treat them." Approximately one-third of all Americans have some element of chronic pain; many have been living with their pain for more than five years and experience pain almost six days a week. Up to 700 million workdays are lost in the U.S. each year as a result of pain-related disabilities. Moreover, chronic pain has a significant economic impact, with estimated direct and indirect costs in the United States exceeding $100 billion annually. Tramadol is a non-scheduled centrally-acting synthetic opioid analgesic that has been used in the treatment of moderate to moderately severe pain since its introduction in the United States in 1995. Ultram ER uses Biovail's innovative Smartcoat(TM) technology* to produce an extended-release tablet that provides appropriate patients effective pain control over a 24-hour period in a convenient once-daily form of tramadol. In contrast, patients may need to take immediate release tramadol tablets every 4-6 hours for pain relief. "The development of a once-daily formulation of tramadol is indicative of how an innovative drug-delivery technology can overcome the most difficult formulation enhancement challenges," said Douglas Squires, PhD, Chief Executive Officer of Biovail Corporation. Ultram ER is contraindicated in any situation where opioids are contraindicated, including in those patients with a history of anaphylactoid reactions to opioids. Seizures have been reported in patients receiving tramadol. The risk of seizure is increased with doses of tramadol above the recommended range and in patients taking certain medications such as tricyclic antidepressants, selective serotonin reuptake inhibitors or opioids. Administration of tramadol may enhance the seizure risk in patients taking MAO inhibitors, neuroleptics, other drugs that reduce the seizure threshold, or in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections). Tramadol, like other opioids used in analgesia, can be abused. Ultram ER should not be used in patients who are suicidal or addiction-prone, or taken with alcohol-containing beverages. In clinical trials the most frequently reported side effects associated with Ultram ER were dizziness, nausea, constipation, somnolence, and flushing. Ultram ER Extended-Release Tablets are intended for oral use only and should be swallowed whole. The tablets should not be chewed, crushed, or split. Ultram ER should not be administered at a dose exceeding 300 mg per day. * Smartcoat(TM) technology is a trademark of Biovail.
SOURCE: Ortho-McNeil, Inc.
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