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Purdue Pharma

Who We Are

Purdue Pharma L.P., a privately held pharmaceutical company founded by physicians, is focused on meeting the needs of health care providers and the patients in their care.

Together with its independent associated companies, Purdue is dedicated to finding, developing and bringing to market new medicines and related products that improve health outcomes. The company has long been known for its pioneering research on persistent pain, a principal cause of human suffering.

Purdue also has a growing line of nonprescription products including laxatives, microbicides and nutraceuticals. The company is dedicated to serving the evolving needs of health care providers, patients and caregivers with innovative prescription and nonprescription medicines. A commitment to innovation and caring spans every aspect of the organization, from discovering and launching new medicines to demonstrating their medical value.

Purdue has led the battle against inadequate treatment of pain by developing sustained-release medications to manage pain and provide meaningful benefits for patients. Its sales, marketing and medical education professionals provide the health care community with comprehensive educational materials and programs relating to pain management.

In 1993, Purdue established Partners Against Pain^® (www.partners​against​pain.com) as a resource to help patients, caregivers and health care providers advance standards of pain care and alleviate unnecessary suffering through education and advocacy. Purdue also has assumed a leading role in addressing the serious public health problem of prescription drug abuse, supporting programs intended to help stem this problem.

At its research facilities in Cranbury, N.J., Purdue scientists are discovering new compounds to treat pain and developing innovative formulations and delivery systems that improve patient compliance and safety and will be less desirable to drug abusers, while still providing safe and effective pain control for patients.

Purdue’s newest analgesic, Ryzolt^® (tramadol HCl extended-release tablets), is now available 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 should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids.

Ryzolt is contraindicated in patients with severe respiratory depression in unmonitored settings or in the absence of resuscitative equipment. Ryzolt is also contraindicated in patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or in the absence of resuscitative equipment.

Seizures have been reported in patients receiving tramadol hydrochloride within the recommended dosage range. Spontaneous postmarketing reports indicate that seizure risk is increased with doses above the recommended range. Concomitant use of tramadol hydrochloride increases the seizure risk in patients taking other medications that reduce the seizure threshold. Risk for convulsions may also be increased in patients with a history of, or a recognized risk for, seizure.

Do not prescribe Ryzolt for patients who are suicidal or addiction-prone.

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 sush as SSRIs, SNRIs, TCA, 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.

Ryzolt is a μ-agonist opioid. Tramadol, like other opioids used in analgesia, can be abused and is subject to criminal diversion.

Ryzolt should be administered cautiously in patients at risk for respiratory depression and in reduced dosages when administered to patients receiving CNS depressants. Tramadol increases the risk for CNS and respiratory depression in these patients.

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- (NDC 59011-334-30), 200- (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 through a free sample of up to 14 days of Ryzolt, any tablet strength, 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, 2010.^1,2

Ryzolt was developed by Labopharm Inc., of Canada, and approved by the 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- and extended-release characteristics.

Ryzolt demonstrates three areas of activity:

• Binding of parent molecule and M1 metabolite to μ-opioid receptors;
• Weak inhibition of the reuptake of serotonin;
• Weak inhibition of the reuptake of norepinephrine.

Ryzolt may be appropriate for new patients meeting the indication:

• When you don’t feel NSAIDs or COX-2s are appropriate;
• When strong opioids don’t seem warranted.

Median time to Tmax is 4 hours for tramadol, the parent molecule.

Ryzolt offers the convenience of q24h dosing and the ability to titrate to the highest dose of 300 mg q24h in as little as five days, if tolerated.

1. 14 tablets maximum, one prescription only, one strength only—100, 200 or 300 mg. The card’s value is limited to a one-time use per patient per promotional period (program expires 12/31/2010).
2. The Ryzolt Patient Value Card cannot be used with any government programs like Medicaid, Medicare Part D or TriCare and can be used no more frequently than every 24 days and only when accompanied by a valid Ryzolt prescription.

This corporate profile was reviewed and approved by Purdue Pharma.

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