Assessment of indomethacin oral spray for the treatment of oropharyngeal mucositis-induced pain during anticancer therapy

Purpose 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. Method 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. Results 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. Conclusions 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.