Mallinckrodt announced that the FDA has approved a 32mg strength of Exalgo (hydromorphone HCl) extended-release tablets for opioid-tolerant patients with moderate-to-severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time.

The Supplemental New Drug Application (sNDA) for the 32mg tablet was submitted in January 2012 with post-marketing data to support the original application’s compendium of clinical trials demonstrating efficacy and tolerability. It will utilize the same OROS drug delivery system designed to release the opioid analgesic at a controlled rate.

Exalgo is already available in 8mg, 12mg, and 16mg dosage strength tablets. The new 32mg strength tablets are expected to be available in the next few weeks. All Exalgo dosage strengths are subject to the recently approved Risk Evaluation and Mitigation Strategy (REMS) program for all long-acting and extended-release opioids.

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