Swedish pharmaceutical firm Moberg Pharma has enrolled the first patient in a randomised controlled Phase II trial of BUPI, a new topical formulation to treat oral pain.
The trial’s aim is to confirm the promising results secured from several smaller pilot studies, as well as to assess if bupivacaine formulated as a lozenge can be an effective, safe and patient friendly treatment of oral pain.
The company intends to report from the Phase II trial in the first half of 2015.
Moberg Pharma CEO Peter Wolpert said: "After acquiring the BUPI assets in April, the project has progressed rapidly.
"It is exciting that the clinical program now has started for this very promising treatment for severe oral pain. The goal is to make the treatment available to patients within a few years."
More than 40 patients with head and neck cancer suffering from pain due to oral mucositis (OM) will be enrolled in the trial. It will be carried out at Rigshospitalet in Denmark in cooperation with Klinisk Forsknings center, Hvidovre Hospital, who will also be supervising the trial.
OM is a painful inflammation and ulceration of the mucous membranes lining the mouth.
Primary endpoint of the trial will be average oral pain intensity measured by a Visual Analog Scale, a standard method for measuring pain.
During the trial, patients will be randomised to recieve standard pain treatment with or without the addition of a bupivacaine lozenge.
The company said that the product is a new lozenge formulation of bupivacaine, a local anaesthetic with a well-established long acting effect, currently available on the market for other indications as an injectable.
OM 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.