This week the FDA approved Exalgo, the first extended-release form of the opioid pain reliever hydromorphone. Exalgo is for the treatment of moderate to severe chronic pain and can only be given to opioid-tolerant patients. It will be available in 8 mg, 12 mg, and 16 mg dosages.
Designed to be taken once a day, Exalgo is meant to provide steady, around-the-clock pain relief, minimizing the peaks and vallies that inevitably occur with immediate-release pain relievers which have to be taken every few hours.
Exalgo was approved with a risk evaluation and mitigation strategy (REMS) program. I haven't seen the details of the REMS program yet, but it is said to include a patient-friendly medication guide, an education program and “safe-use tools” for physicians.
With all of the FDA's talk about developing REMS for all opioid medications, I found it interesting and encouraging to learn that the REMS approved for Exalgo were actually less restrictive than those initially purposed by Covidien, the manufacturer of Exalgo. It gives me hope that maybe the FDA has been listening to patients' concerns.
Published On: March 03, 2010