Singapore, 10 August 2016 – Homegrown specialty pharmaceutical company iX Biopharma Ltd. (“iX Biopharma” or, together with its subsidiaries, “the Group”) has completed preclinical development for BnoX, a sublingual buprenorphine wafer for acute and severe pain management.
Buprenorphine is known for its poor bioavailability (reported to be 10% or less) when ingested orally. However, by utilising iX Biopharma’s proprietary sublingual technology WaferiX, the bioavailability of buprenorphine is expected to be improved multi-fold and result in greater analgesic effect. Sublingual delivery will thus potentially offer less variability in drug absorption, a more predictable dose and analgesic response to buprenorphine.
In the last two decades, opioids (such as morphine and its derivatives) have been accepted as the gold standard for acute and severe pain management. However, it has been a recent view of the medical community that the long-term use of opioids can lead to hyperalgesia (heightened sensitivity to pain). In May 2016, the Los Angeles Times reported that more than 7 million Americans have abused oxycodone. The drug has also been widely blamed for setting off the nation’s prescription opioid epidemic and has led to major health risks.
In response, the American government has taken an unusual and drastic measure to reduce opioid prescription. In February 2016, the White House, with bipartisan support, put in place a US$1.1 billion budget commitment to address opioid overdose, including to expand buprenorphine prescriptions to overcome drug addiction. A month later, the federal government published the first national standards for the prescription painkillers, recommending the use of alternatives, such as buprenorphine, to highly addictive opioids.
Along with this, there is now an increasing recognition that buprenorphine can be a critical and emerging compound for acute and severe pain management.
The immediate plan for iX Biopharma is to conduct a pharmacokinetic (PK) study on BnoX. Upon successful completion of the study, the Group intends to make this product available for supply to hospitals and registered pharmacies in Australia under the Special Access Scheme exemption set out in Schedule 5A of the Therapeutic Goods Regulation. Commenting on this latest product, Dr Janakan Krishnarajah, Chief Medical Officer of iX Biopharma said, “With prolonged use, traditional opioids have been shown to be accompanied by debilitating side effects and the potential of drug addiction. The development of BnoX is in line with iX Biopharma’s mission to improve the quality of life of individuals suffering from pain. Once commercialised, BnoX, together with the Group’s non-opioid product, Wafermine, will serve as a viable and effective alternative to existing opioids for pain management.”
About iX Biopharma Ltd
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 issues. The Company leverages its patented sublingual drug delivery technology, WaferiX, to develop proprietary products that incorporate pharmacologically active compounds that have been approved by the United States Food and Drug Administration. Its portfolio of products under development include Wafermine and BnoX for pain management, and PheoniX for erectile dysfunction.
Buprenorphine is known for its poor bioavailability (reported to be 10% or less) when ingested orally. However, by utilising iX Biopharma’s proprietary sublingual technology WaferiX, the bioavailability of buprenorphine is expected to be improved multi-fold and result in greater analgesic effect. Sublingual delivery will thus potentially offer less variability in drug absorption, a more predictable dose and analgesic response to buprenorphine.
In the last two decades, opioids (such as morphine and its derivatives) have been accepted as the gold standard for acute and severe pain management. However, it has been a recent view of the medical community that the long-term use of opioids can lead to hyperalgesia (heightened sensitivity to pain). In May 2016, the Los Angeles Times reported that more than 7 million Americans have abused oxycodone. The drug has also been widely blamed for setting off the nation’s prescription opioid epidemic and has led to major health risks.
In response, the American government has taken an unusual and drastic measure to reduce opioid prescription. In February 2016, the White House, with bipartisan support, put in place a US$1.1 billion budget commitment to address opioid overdose, including to expand buprenorphine prescriptions to overcome drug addiction. A month later, the federal government published the first national standards for the prescription painkillers, recommending the use of alternatives, such as buprenorphine, to highly addictive opioids.
Along with this, there is now an increasing recognition that buprenorphine can be a critical and emerging compound for acute and severe pain management.
The immediate plan for iX Biopharma is to conduct a pharmacokinetic (PK) study on BnoX. Upon successful completion of the study, the Group intends to make this product available for supply to hospitals and registered pharmacies in Australia under the Special Access Scheme exemption set out in Schedule 5A of the Therapeutic Goods Regulation. Commenting on this latest product, Dr Janakan Krishnarajah, Chief Medical Officer of iX Biopharma said, “With prolonged use, traditional opioids have been shown to be accompanied by debilitating side effects and the potential of drug addiction. The development of BnoX is in line with iX Biopharma’s mission to improve the quality of life of individuals suffering from pain. Once commercialised, BnoX, together with the Group’s non-opioid product, Wafermine, will serve as a viable and effective alternative to existing opioids for pain management.”
About iX Biopharma Ltd
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 issues. The Company leverages its patented sublingual drug delivery technology, WaferiX, to develop proprietary products that incorporate pharmacologically active compounds that have been approved by the United States Food and Drug Administration. Its portfolio of products under development include Wafermine and BnoX for pain management, and PheoniX for erectile dysfunction.
