Mallinckrodt receives FDA approval for 32 mg tablet strength of EXALGO

The U.S. Food and Drug Administration (FDA) has notified Mallinckrodt, the pharmaceuticals business of Covidien (NYSE:COV), 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 Americans 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. 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.