iX Biopharma Ltd, a homegrown specialty pharmaceutical company, has announced 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.”
Sublingual buprenorphine wafer, bnox
.jpg)
.png)
.jpg)