New Once-Daily RYZOLT™ (tramadol HCl extended-release tablets) Now Available in the U.S.
Stamford, CT – May 7, 2009 – RYZOLT™ (tramadol HCl extended-release tablets) is now available from Purdue Pharma L.P. for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.
RYZOLT’s active ingredient, tramadol, is a centrally-acting synthetic opioid analgesic that binds to the µ -opioid receptor and also inhibits the reuptake of both serotonin and norepinephrine. Taken once every 24 hours, RYZOLT offers convenient dosing in 100 mg (NDC 59011-334-30), 200 mg (NDC 59011-335-30), and 300 mg (NDC 59011-336-30) tablet strengths. Eligible patients prescribed RYZOLT may receive a special RYZOLT Patient Value Card from their physician that can be applied at the pharmacy for immediate value of up to 14 days of RYZOLT, and extended value of up to $35 dollars off their out-of-pocket costs for each prescription filled (after paying the first $10), until December 31, 20101.
RYZOLT was developed by Labopharm Inc. (NASDAQ:DDSS; TSX:DDS) of Canada and approved by the U.S. Food and Drug Administration (FDA) in December 2008. The product is based on Labopharm’s proprietary Contramid® controlled-release technology, featuring a dual-matrix delivery system with both immediate-release and extended-release characteristics.
“RYZOLT expands our commitment to provide a range of pain management treatments for healthcare professionals to consider when they diagnose and treat the many painful conditions that affect millions of Americans,” said John H. Stewart, President and CEO of Purdue Pharma L.P.
More information and complete prescribing information for RYZOLT can be found at http://www.pharma.com/pi/prescription/Ryzolt.pdf. Please read the following important safety information.
Important Safety Information
RYZOLT is contraindicated in patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product, or opioids. RYZOLT is also contraindicated in patients with significant respiratory depression in unmonitored settings or the absence of resuscitative equipment and in patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment.
Seizures have been reported in patients receiving tramadol hydrochloride within the recommended dosage range. Seizure risk is increased with doses above the recommended range. Concomitant use of tramadol hydrochloride increases the seizure risk in patients taking selective serotonin reuptake inhibitors (SSRI antidepressants or anorectics), tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or other opioids. Administration of RYZOLT may enhance the seizure risk in patients taking monoamine oxidase (MAO) inhibitors, neuroleptics, or other drugs that reduce the seizure threshold. Risk of convulsions may also be increased in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, certain metabolic disorders, alcohol and drug withdrawal and CNS infections).
The development of a potentially life-threatening serotonin syndrome may occur with the use of tramadol products, including RYZOLT, particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs, and triptans, with drugs which impair metabolism of serotonin (including MAOIs), and with drugs which impair metabolism of tramadol (CYP2D6 and CYP3A4 inhibitors). This may occur within the recommended dose.
Do not prescribe RYZOLT for patients who are suicidal or addiction-prone.
Like other opioid agonists, legal or illicit, tramadol can be abused. RYZOLT could be abused by breaking, crushing, chewing, or dissolving the product which can result in the uncontrolled delivery of the opioid, and as a consequence poses a significant risk of overdose and death. This risk is increased with concurrent abuse of alcohol and other substances.
RYZOLT should be administered cautiously in patients at risk for respiratory depression. In these patients, alternative non-opioid analgesics should be considered. When large doses of tramadol are administered with anesthetic medications or alcohol, respiratory depression may result.
The most common side effects reported with RYZOLT were nausea, constipation, dizziness, somnolence, vomiting, pruritus, and headache.
About Purdue Pharma L.P.
Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.
About Labopharm Inc.
Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company’s lead product, a once-daily formulation of tramadol, is being commercially launched in key markets globally and its second product, a novel formulation of trazodone for the treatment of major depressive disorder, is under regulatory review by the FDA. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm’s vision is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit www.paladin-labs.com.
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- 14 tablets maximum, one prescription only, one strength only – 100 mg, 200 mg, or 300 mg. The card’s value is limited to a one time use per patient per promotional period (program expires 12/31/2010).
Contact: James Heins
Mike Meo, Cooney Waters