FDA Approves Higher Dose of Hydromorphone

Emma Hitt, PhD


August 29, 2012

August 29, 2012 — The US Food and Drug Administration (FDA) has approved a 32-mg tablet strength of hydromorphone HCI extended-release tablets (Exalgo, Mallinckrodt) for opioid-tolerant patients with moderate to severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended time.

Lower doses (tablets of 8, 12, and 16 mg) were approved in March 2010, and the supplemental New Drug Application (sNDA) for the current approval was submitted in January 2012, along with postmarketing data to support the original application's compendium of clinical trials demonstrating efficacy and tolerability.

According to the manufacturer's written release, the 32-mg tablet will be available in the next few weeks. This product uses the OROS drug delivery system, which allows the release of controlled drug levels over several days. The product is more resistant than other opioid formulations to tampering through chewing, crushing, and dissolving.

Regarding the new, higher dose, Thomas Smith, MD, Mallinckrodt's chief medical officer, pointed out that the new tablet "represents an important milestone as 32 mg was the median effective dose upon which patients were stabilized during the pivotal trial."

As reported by Medscape Medical News, since July of this year, hydromorphone HCI extended-release tablets have been subject to a risk evaluation and mitigation strategy (REMS) program that applies to all long-acting and extended-release opioids. The program will also apply to the 32-mg dose.

"The three primary components of this REMS program are training for prescribers in the form of continuing medical education (CME) initiatives, which will be available by March 2013; updated medication guides for each opioid and a patient counseling document; and assessment and auditing to ensure the reach and effectiveness of prescriber training," the manufacturer release states.


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