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On March 1, the FDA approved Exalgo® (extended-release hydromorphone HCl) 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.
Exalgo has been in development for around 10 years, with major setbacks due to FDA concerns over potential abuse. This medication employs a relatively unique technology known as the OROS® Push-Pull™ System (osmotic-controlled release oral delivery system), which allows the drug to be released from the capsule slowly over 24 hours and produces stable drug levels in the body. The cause for concern is that tampering with the capsules changes the release mechanism from extended release to immediate release. While the active ingredient in Exalgo, hydromorphone, is currently available in an immediate-release preparation, the doses are significantly lower than those provided by the extended-release version. Therefore, abuse of Exalgo would result in extremely high doses of hydromorphone, which may lead to respiratory depression and even death.
Because Exalgo is an extended-release opioid product, the FDA has required the development of a Risk Evaluation and Mitigation Strategy (REMS) to ensure safe use of the product. While still being finalized, the manufacturer has developed the Exalgo Alliance program, which will be mandatory for all patients taking the medication. Tentatively, the requirements will be:
Exalgo may only be prescribed by an authorized prescriber who is enrolled in the program
Exalgo may only be used by patients who have signed a prescriber-patient medication agreement
Exalgo may only be dispensed by pharmacies that are enrolled in the program
Pharmacies must obtain verification of prescription eligibility prior to each Exalgo dispensing
Distributors of pharmaceutical products must agree to sell Exalgo only to enrolled pharmacies
REFERENCES:
Associated Press. FDA clears way for painkiller Exalgo. Boston Globe. Published: 3/3/2010.
Accessed: 3/5/2010. Available from: http://www.boston.com/business/healthcare/articles/2010/03/03/fda_clears_way_for_painkiller_exalgo/
FDA homepage. Accessed: 3/5/10. Available from: www.fda.gov
Disclaimer: This content is intended for informational purposes only and is in no way intended to take the place of proper medical supervision and advice. If you have any questions or concerns about your client''s health, please contact a medical prescriber. The information contained herein is known to be correct at the time of posting; however, the content is not guaranteed due to the dynamic nature of healthcare.
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