Moberg Pharma announced that the first patient has been included in a randomized controlled phase II study with BUPI, a novel topical formulation for the treatment of oral pain. The aim is to confirm the promising results gained from several smaller pilot studies and to evaluate if bupivacaine formulated as a lozenge can be an effective, safe and patient friendly treatment of oral pain. The results are expected in the first half of 2015.
The phase II study is conducted at Rigshospitalet in Denmark in cooperation with and under the supervision of Klinisk Forskningscenter, Hvidovre Hospital and will recruit up to 40 patients with head and neck cancer suffering from pain due to oral mucositis. The primary endpoint will be average oral pain intensity measured by a Visual Analog Scale, a standard method for measuring pain. The patients will be randomized to get standard pain treatment with or without the addition of a bupivacaine lozenge.
The product is a novel 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. The original innovation came out of work by clinicians at Hvidovre Hospital, Copenhagen, Denmark facilitated by XOventure GmbH and SEED Capital Denmark. Moberg Pharma acquired the rights to the product in April 2014.
Source: Moberg Pharma pressrelease