Assessment of indomethacin oral spray for the treatment of oropharyngeal mucositis-induced pain during anticancer therapy
The efficacy and safety of indomethacin (IM) oral spray (OS) as a pain control therapy for oropharyngeal mucositis due to anticancer chemo- and radiotherapy were assessed in patients with head and neck carcinomas and haematological tumours.
We observed 35 patients (male/female, 20/15; 53 ± 17 years) with oropharyngeal mucositis who were treated with IM-OS preparation for pain relief at University of Tsukuba Hospital, Japan. Analgesic effects were assessed using the six-grade face scale for pain in 28 patients at the start of IM oral spray treatment. Systemic exposure was assessed by determining urinary excretions of IM in seven patients.
Pain relief was achieved in 26 (93%) patients at 25 (5–60) min after applying the IM-OS preparation (15.6 ± 3.4 μg/kg) and analgesic effects were maintained for 120 (10–360) min. The pain was significantly decreased after using the spray (3.6 ± 0.7 vs. 2.4 ± 0.9, p < 0.01). Moreover, urinary IM excretion rates after applying the IM spray preparation were 1.8 ± 0.8% of the IM oral spray dose (130.5 ± 77.7 μg/kg/day), which was markedly lower than that following oral administration of IM (60%). No adverse events were observed following application of the spray.
The present IM spray is an effective and safe preparation for pain relief and can be used as an alternative therapeutic option for oropharyngeal mucositis in cancer patients.
KeywordsIndomethacin Indomethacin oral spray preparation Oral mucositis Oropharyngeal mucositis Pain control Cancer patients
This work was supported by JSPS KAKENHI Grant Numbers 15K18916. The sponsor had no role in study design, data collection, data analysis, or data interpretation.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
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