Moberg Pharma AB announced positive top -line results from a phase II-study with BUPI for the treatment of pain due to oral mucositis in patients with head and neck cancer. BUPI achieved a statistically significant reduction in pain. 32 patients completed the phase II-study in which the efficacy of BUPI was compared to standard treatment for pain in the oral cavity.

The open clinical study was conducted at two hospitals in Denmark. The primary endpoint was a measurement of pain in the mouth or pharynx 60 minutes post administration of BUPI compared to the average pain during the day for the control group. The group treated with BUPI had 23% reduction in pain compared to the control group (VAS 37.47 in BUPI vs.

48.94 in control, p=0.0326). Both groups were allowed to use standard treatment options for pain during the study. The control group was furthermore allowed to use locally acting anesthetics for the oral cavity, in the form of a lidocaine gel.

The difference in the mouth (pharynx excluded) was even more pronounced. Treatment with BUPI resulted in an additional pain reduction of 46% compared to standard treatment (VAS 17.74 vs. 33.03, p=0.0027).

No serious adverse events were reported among the patients treated with BUPI.