FDA Approves Exalgo 32 mg

FDA Approves Mallinckrodt's Exalgo (hydromorphone HCl) Extended-Release Tablets 32 mg (CII) for Opioid-Tolerant Patients with Moderate-to-Severe Chronic Pain

ST. LOUIS--(BUSINESS WIRE)--Aug 27, 2012 - The U.S. Food and Drug Administration (FDA) has notified Mallinckrodt, the pharmaceuticals business of Covidien, that it has approved a 32 mg tablet strength of Exalgo (hydromorphone HCI) Extended-Release Tablets (CII) for opioid-tolerant patients with moderate-to-severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time. The FDA approved the 8, 12 and 16 mg tablets of Exalgo in March 2010 and the Supplemental New Drug Application (sNDA) for the 32 mg tablet was submitted in January 2012 with post-marketing data to support the original application's compendium of clinical trials demonstrating efficacy and tolerability. The Exalgo 32 mg tablet strength will be available in the next few weeks.

“We believe that the new 32 mg tablet - delivered by the same extended-release OROS® technology used with the 8, 12, and 16 mg tablets - will provide an established pharmacologic profile and analgesic potency of once-daily hydromorphone. This new Exalgo 32 mg tablet represents an important milestone as 32 mg was the median effective dose upon which patients were stabilized during the pivotal trial,” said Thomas Smith, M.D., Chief Medical Officer, Mallinckrodt. “By providing a variety of tablet strengths, we hope that physicians and opioid-tolerant patients can work together to develop and tailor a treatment regimen that adequately and appropriately controls their chronic pain.”

Exalgo utilizes the OROS drug delivery system designed to release the opioid analgesic at a controlled rate. By providing a steady release of hydromorphone throughout the day once steady-state is achieved after three to four days, the drug is formulated to help minimize the peaks and valleys that are sometimes experienced by chronic pain patients who rely on immediate-release products that are dosed at more frequent intervals. Additionally, the physical properties of Exalgo may make it difficult to extract the active ingredient using common forms of physical and chemical tampering, including chewing, crushing and dissolving. OROS technology has been used in products for various therapeutic areas for more than 30 years.

There are an estimated 116 million Americans1 with chronic pain. According to a survey of 1,000 patients, many people have made life-altering changes such as taking disability leave from work, changing jobs altogether, getting help with activities of daily living and moving to a home that is easier to manage.2 While opioid therapy to help reduce their pain levels is not appropriate for all of these patients, it is critically important for all patients to work with their physicians to find the right treatment, including the right dosing regimen if medications are used.

“Physicians may try as many as five types of opioids before finding a treatment plan that provides pain relief to patients,” said Dr. Joseph Shurman, Chairman, Pain Management, at Scripps Memorial Hospital. “Sustained release treatments like Exalgo help patients avoid fluctuations in blood plasma levels and a new tablet strength provides more options for physicians to use with their opioid-tolerant patients."

All Exalgo dosage strengths, including the new 32 mg tablet, are subject to the recently approved Risk Evaluation and Mitigation Strategy (REMS) program for all long-acting and extended-release opioids. The three primary components of this REMS program are: training for prescribers in the form of continuing medical education (CME) initiatives, which will be available by March 2013; updated medication guides for each opioid and a patient counseling document; and assessment and auditing to ensure the reach and effectiveness of prescriber training.

Mallinckrodt fully supports the efforts coordinated by the White House Office of National Drug Control Policy to address the abuse, misuse and overdose of these opioid analgesics.

In order to ensure a smooth transition to the class-wide REMS program, Mallinckrodt will maintain the current Exalgo REMS program web site at www.Exalgorems.com and continue to provide important Exalgo prescribing information, with a focus on appropriate patient selection and dosing, to new prescribers. In addition, Mallinckrodt continues to provide to health care professionals, patients and caregivers more than 60 educational tools, at no cost, on the safe and appropriate prescribing, dispensing and use of opioids at www.caresalliance.org.

Mallinckrodt is committed to ensuring that patients have access to medications that adequately control their pain. If a patient cannot afford their Exalgo prescription, Mallinckrodt may be able to help. More information about the Patient Assistance Program is available by calling 1-800-259-7765. Some rules and restrictions may apply.

Beyond the Patient Assistance Program, Mallinckrodt also offers Exalgo Co-Pay Cards to certain eligible patients. Those eligible patients can show their Co-Pay Card to their pharmacist and save every time they fill their prescription for Exalgo. If a patient did not receive a Co-Pay Card enrollment form from their physician, they can access one by visiting http://www.Exalgo.com/patient/Exalgo-co-pay-card.aspx.

About Covidien

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2011 revenue of $11.6 billion, Covidien has 43,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

1 American Academy of Pain Medicine (AAPM) Facts and Figures on Pain. American Academy of Pain Medicine website. Retrieved on April 24, 2012 http://www.painmed.org/patient/facts.html.

2 Peter D. Hart Research Associates. (2003). Americans in Pain: A SURVEY AMONG ADULTS NATIONWIDE CONDUCTED FOR RESEARCH!AMERICA. Retrieved on May 15, 2012 from http://www.researchamerica.org/uploads/poll2003pain.pdf.

Contact: Covidien
Lynn Phillips, 314-654-3263
Manager, Media Relations
Pharmaceuticals
lynn.phillips@covidien.com
or
Coleman Lannum, CFA, 508-452-4343
Vice President
Investor Relations
cole.lannum@covidien.com
or
Stephen Littlejohn, 314-654-6595
Vice President, Communications
Pharmaceuticals
stephen.littlejohn@covidien.com
or
Todd Carpenter, 508-452-4363
Director
Investor Relations
todd.carpenter@covidien.com

 

Posted: August 2012

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Exalgo (hydromorphone) FDA Approval History

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