Mallinckrodt receives FDA approval for 32 mg tablet strength of EXALGO

Published on August 27, 2012 at 9:59 AM · No Comments

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.

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