FDA Updates Labeling for OIC Medication

Article

Most patients on opioids experience one if not more adverse events, many gastrointestinal, during the course of therapy.

The US Food and Drug Administration (FDA) has updated the indication of a number of products, including naloxegol (Movantik, AstraZeneca), to clarify their use in patients "to include patients with chronic pain related to prior cancer or its treatment who do not require frequent opioid dosage escalation."

Naloxegol tablets are for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent opioid dosage escalation. This label update follows initial FDA approval for Movantik in 2014 as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.

Overall, cancer survival rates are increasing, making pain related to prior cancer or its treatment an important health care issue. A meta-analysis investigating the prevalence of pain showed that approximately 40% of patients experience pain after curative cancer treatment. This review was based on literature published from September 2005 through January 2014.

Most patients on opioids experience one if not more adverse events, many gastrointestinal, during the course of therapy. OIC is by far the most prevalent and persistent AE, with some estimates being as high as 40% in patients receiving opioids.1-4

References

Kumar L, Barker C, Emmanuel A. Opioid-induced constipation: pathophysiology, clinical consequences, and management. Gastroenterol Res Pract. 2014;2014:141737. doi:10.1155/2014/141737.

Satyavan K. Managing opioid-induced constipation. Pharmacy Times website. Published September 15, 2009. Accessed July 13, 2016.

Kalso E, Edwards JE, Moore RA, McQuay HJ. Opioids in chronic non-cancer pain: systematic review of efficacy and safety. Pain. 2004;112(3):372-380. doi:10.1016/j.pain.2004.09.019.

Camilleri M. Opioid-induced constipation: challenges and therapeutic opportunities. Am J Gastroenterol. 2011;106(5):835-842. doi:10.1038/ajg.2011.30.

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