Biopharmaceutical company Zalicus has received the US FDA approval for its supplemental new drug application (sNDA) for the 32 mg dose strength of Exalgo(hydromorphone HCl) Extended-Release Tablets (CII).
Exalgo is used to treat moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.
Exalgo uses OROS technology to release hydromorphone throughout the day.
Zalicus president and CEO Mark Corrigan said more than one hundred million Americans suffer from debilitating chronic pain that impacts quality of life.
"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," Corrigan added.
In June 2009, Mallinckrodt acquired Exalgo rights while Zalicus will receive tiered royalties on net sales of drug from Mallinckrodt.
FDA approved existing doses of 8, 12 and 16 mg of Exalgo in March 2010.