Moberg announces positive data for BUPI in oral mucositis

Moberg Pharma has 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.

Oral mucositis is a painful inflammation and ulceration of the mucous membranes lining the mouth. Oral mucositis is a common and often debilitating complication of cancer treatment which affects 80% of patients with head and neck cancer receiving radiotherapy, almost all patients undergoing bone marrow transplantation, and a wide range of patients receiving chemotherapy. Oral mucositis makes the patient less likely to comply with their cancer treatment, increases mortality and morbidity and contributes to rising health care costs.

BUPI resulted in an additional pain reduction in the mouth of 46%

Thirty-two patients completed the Phase II study in which the efficacy of BUPI was compared to standard treatment for pain in the oral cavity. 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. Both groups were allowed to use standard treatment options for pain during the study. The control group was furthermore allowed to use locally acting anaesthetics 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. No serious adverse events were reported among the patients treated with BUPI.

Commenting on the results from the trial, Kjell Rensfeldt, VP Research and Development at Moberg Pharma, said, “This study shows that BUPI provided additional pain reduction to levels below VAS 40 in a patient population for which it is difficult to achieve adequate pain relief. Developing a new formulation of bupivacaine, intended for self-administration at home, requires a thorough evaluation of the safety profile of the product. Moberg Pharma will now proceed with in-depth analyses of all other data collected in this study, in order to guide further clinical development of BUPI.”