Singapore, 15 May 2017 – Homegrown specialty pharmaceutical company iX Biopharma Ltd. (“iX Biopharma” or, together with its subsidiaries, “the Group”) is pleased to announce the results of BUP001, a pharmacokinetic study of its novel sublingual buprenorphine wafer, BnoX. BnoX, which uses the Group’s patented sublingual drug delivery technology, WaferiX, is one of the Group’s products under development for pain management.
The primary objective of the study was to investigate the absolute bioavailability and tolerability of BnoX. (It is generally known that the oral bioavailability of buprenorphine is very low and variable, leading to unpredictable clinical effects).
The absolute bioavailability of BnoX was 45.4% with time to maximum plasma concentration (Tmax) of 1 hour. This compares favourably to the only marketed sublingual formulation for pain, Temgesic® which has a reported bioavailability of 35% and Tmax of 2-4 hours1. BnoX wafers were safe and well-tolerated.
Dr Janakan Krishnarajah, Chief Medical Officer said: “We are very pleased with the outcomes from BUP001 study. The results suggest that BnoX appears to have a superior pharmacokinetic profile compared to the marketed Temgesic® sublingual tablet, and may provide enhanced clinical utility in the management of both acute and chronic pain.”
Dr Krishnarajah will be presenting this exciting study result at the Annual Scientific Meeting of the Australian and New Zealand College of Anaesthetists to be held in Brisbane, Australia on Monday, 15 May 2017. This is the premier annual conference for anaesthetists in Australia and New Zealand, and 1,800 attendees are expected.
1 Temgesic® Product Information
iX Biopharma Ltd is a Singapore public-listed specialty pharmaceutical company, with manufacturing and laboratory testing facilities in Australia. The Group is focused on the development and commercialisation of innovative therapies for improving the quality of life of those suffering from pain and other health conditions. The Company leverages its patented sublingual drug delivery technology, WaferiX, to develop proprietary products that incorporate pharmacologically active compounds that have been approved by regulatory bodies. Its pipeline of products under development includes Wafermine and BnoX for pain management; it is also in the process of commercialising PheoniX for erectile dysfunction and WafeRest for improved sleep quality.
