FDA approves Mallinckrodt's EXALGO (32 mg) sNDA to manage opioid-related pain

Published on August 27, 2012 at 9:30 AM · No Comments

Zalicus Inc. (NASDAQ: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) filed by Mallinckrodt Inc., a subsidiary of Covidien plc, for the 32 mg dose strength of EXALGO® (hydromorphone HCl) Extended-Release Tablets (CII), for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

"More than one hundred million Americans suffer from debilitating chronic pain that negatively impacts their quality of life; including their ability to work, attend school and care for their families," commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. "By providing a variety of tablet strengths of EXALGO, physicians and patients can work together to develop and tailor a treatment regimen that optimally controls their pain."

The rights to EXALGO were acquired by Mallinckrodt LLC, the pharmaceuticals business of Covidien plc, in June 2009 for $15 million in upfront payments, additional development funding of up to $16 million and a $40 million FDA approval milestone payment. Zalicus receives tiered royalties on net sales of EXALGO by Mallinckrodt.

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