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Exalgo® (hydromorphone HCl) Extended-Release Tablets (CII)


On March 1, 2010, the U.S. Food and Drug Administration (FDA) approved the New Drug Application for Exalgo® (hydromorphone HCl) extended-release tablets (8, 12 and 16 mg), 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. In August 2012, the FDA approved a supplemental new drug application for the 32 mg dose strength of Exalgo.


Exalgo is an extended-release formulation of hydromorphone.  Hydromorphone is a Schedule II opioid that has been used for many years. Other oral hydromorphone products currently available in the U.S. are immediate release formulations, requiring dosing several times per day. Exalgo employs the OROS® PUSH-PULL™ osmotic delivery system designed to release hydromorphone at a controlled rate over an extended period of time allowing for once-daily administration.  An identical once-daily formulation, under the trade name JURNISTA®, has been launched in several countries by Janssen-Cilag. JURNISTA® was first launched in Germany in August 2006.


The U.S. commercial rights to Exalgo were acquired in June 2009 by Mallinckrodt. Under the agreement, Mallinckrodt is responsible for all commercialization activities for Exalgo in the United States, including marketing and sales. Exalgo was launched in April 2010, and Zalicus receives tiered royalties on net sales of Exalgo by Mallinckrodt.


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