Indomethacin oral spray (IM-OS) is a safe and effective option in the treatment of oropharyngeal mucositis (OM) pain in patients with cancer, according to a study published in Supportive Care in Cancer.

OM is a commonly observed adverse effect of chemotherapy and radiation therapy that impacts quality of life and often leads to therapy disruption. Although several treatment options are available for OM, including opioids and NSAIDs, most are inappropriate for patients with cancer due to the risk of kidney dysfunction and insufficient pain relief.

The study enrolled 35 patients with head and neck carcinomas and hematologic tumors who developed OM that was treated with IM-OS. Pain relief was assessed using the six-grade face scale for pain, and urinalysis was performed to determine the systemic exposure of indomethacin.

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Onset of pain relief was experienced in 26 of 35 (93%) patients at a median 25 minutes after administration of IM-OS at 15.6 ± 3.4 μg/kg.

Analgesia was maintained for 120 minutes.

Patients reported a significant decrease in pain as reported on the 6-grade face scale score (3.6 ± 0.7 vs 2.4 ± 0.9; P <.01). This effect rate was consistent in patients receiving IM-OS alone or in conjunction with NSAIDs or opioids.

Urinalyses were conducted in patients after applying IM-OS at 7.7 ± 4.8 mg/day in order to assess systemic exposure. Excretion rates were observed to be 1.8 ± 0.8% of IM-OS dose, which is much lower than the excretion rates observed after oral administration.

No adverse effects were reported after IM-OS administration.

Study authors conclude that “the present observations of the IM-OS indicate an effective and safe pain relief therapy and warrant consideration as an alternative option for OM due to anticancer therapy.”


1. Momo K, Nagaoka H, Kizawa Y, et al. Assessment of indomethacin oral spray for the treatment of oropharyngeal mucositis-induced pain during anticancer therapy [published online July 18, 2017]. Support Care Cancer. doi: 10.1007/s00520-017-3817-2