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BUPI meets a large demand for pain relief for patients with inflammation and ulceration of the oral mucous membranes (oral mucositis or OM), a serious complication following cancer treatment that prevents completed treatment. The product is in a late clinical phase and has the potential to become the leading treatment in the field according to a study among American physicians.

BUPI is a lozenge with bupivacaine intended for pain relief in association with oral mucositis, a serious complication following cancer treatment such as radiation of tumors. OM also affects certain patients with other forms of cancer or as a result of transplantation. The complication prevents these patients from completing their cancer treatment and results in great suffering and expensive hospital care.

Discussions are currently being held with potential partners primarily in North America and Europe.

Market overview
Patent protection is granted until 2032-2033 in several major markets. In the U.S. alone, OM affects around 400,000 patients. The company estimates the annual sales potential for BUPI at USD 100-200 million in U.S, given successful commercialization for oral mucositis and at least one other indication. This estimation was validated in a physician survey and market analysis made in the U.S. in 2018.

Clinical development
The Phase 2 results showed that BUPI achieved a statistically significant reduction of pain in the oral cavity compared with standard treatment. The primary endpoint, which was met with high statistical significance, was a measurement of pain in the mouth or pharynx 60 minutes’ post administration of BUPI, compared with the average pain during the day for the control group. The group treated with BUPI had a 31% reduction in pain (p=0.0032). Both groups had access to standard treatment options for pain during the study. The control group was also allowed to use another locally acting anesthetic for the oral cavity in the form of a lidocaine gel. Moreover, the difference in the mouth, excluding the pharynx, was more significant, with BUPI reducing the pain by 50% compared with standard treatment (p=0.0002).