Jul 18, 2022 in Diagnostics, Press Releases
XPhyto Pursues Potential Application of its Oral Dissolvable Biosensor Inflammation Test for Buprenorphine-related Dental Disease
Vancouver, Canada, and Uttenweiler, Germany (July 18, 2022) – XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”) is pleased to report a significant potential market opportunity for its oral dissolvable (“ODF”) biosensor screening tests for oral inflammation. Certain buprenorphine medicines prescribed to treat opioid use disorder (“OUD”) and pain have been recently associated with numerous serious oral health problems requiring medical intervention. Buprenorphine is a medication approved by the U.S. Food and Drug Administration (the “FDA”) to treat OUD as a medication-assisted treatment (MAT). The number of US adolescent and adult individuals with OUD in 2019 was estimated between 6.7–7.6 million. XPhyto is investigating the potential application of one or more of its ODF biosensor screening tests for oral inflammation to detect buprenorphine-related dental problems.
This year, the FDA issued a Drug Safety Communication (“DSC”) titled “FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain.” The DSC notes that the dental problems include “tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues.” Notwithstanding the seriousness of the side-effects, the FDA is recommending the continued use of these medications as the benefits outweigh the risks and oral care can assist. The global buprenorphine market is expected to surpass USD $10.9 billion by 2027 according to Coherent Market Insights (CMI).
XPhyto’s proprietary ODF biosensor development portfolio includes multiple oral health products, including for the detection of stomatitis, periodontitis, and periimplantitis. The Company’s first ODF biosensor screening product is for general oral inflammation. Positive detection of the causative inflammatory agents results in an enzymatic release of a bitter compound in the user’s mouth, with no medical training, analytical equipment or power supply required. The oral inflammation biosensor is designed to function as a simple, low-cost, and self-administered screening test to identify users for follow-up medical testing. The Company’s oral dissolvable inflammation screening test was EU registered in late 2021 and is currently licensed for marketing and sale in Europe.
The Company is currently investigating the potential application of one or more of its oral health biosensor screening tests for the detection of buprenorphine-related dental problems. Requirements for clinical evaluation for the purpose of commercial registration and/or approval will be released once established. The company expects to provide further updates on its oral health and infectious disease screening test programs in the coming weeks.
XPhyto’s pipeline of biosensor screening products for inflammatory, bacterial and viral infectious diseases includes stomatitis, periimplantitis, periodontitis, group A strep, influenza A, and covid-19. This suite of biosensor products positions the Company within the global biosensor and oral health markets which are expected to reach US$42 billion by 2027 according to Global Market Insights and MedicalExpo e-magazine and projected to reach US$698.8 billion by 2030.