FDA Approves Revised Label of Opioid-Induced Constipation Drug

The FDA recently updated the indication of naloxegol (Movantik) tablets for the treatment of opioid-induced constipation (OIC) in patients with chronic non-cancer pain, according to a press release.

The label now includes patients with chronic pain resulting from previous cancer or its treatment, and those who do not require continual opioid dose escalation.

Naloxegol was first approved in 2014 as the first peripherally-acting mu-opioid receptor antagonist for OIC in patients with non-cancer pain, according to the release.

The indication update outlines that patients who have chronic pain resulting from previous cancer or its treatment and those who do not need continual dose escalation are included in the approved indication, according to the release. Previously, it may have been unclear if these patients were included.

As cancer survival rates increase, treatment options for pain related to prior disease have become important. A meta-analysis of several studies revealed that 40% of patients experience pain following cancer treatment, making pain management necessary.

Opioids work by blocking pain signals in the central nervous system, but also bind to receptors in the bowel, resulting in constipation. In a study of nearly 500 patients with non-cancer pain with OIC, 71% reported little to no benefit from their constipation treatments at baseline, according to the release.

These findings highlight the need for additional options for patients with non-cancer pain related to previous disease or its treatment.