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.