Prevora has first-in-class approvals to prevent dental decay in high risk adults in Canada (DIN02046245), the United Kingdom (PL30669) and Ireland (PA1205). The European Medicines Agency has issued a positive opinion for Prevora (EMA/H/A-29/1258) as part its Mutual Recognition arbitration process. This EMA opinion is expected to facilitate a successful Mutual Recognition process to EU member states, at the request of CHX. CHX intends to trigger Mutual Recognition in certain member states upon establishing product distribution.
CHX is preparing a do-able, low-risk, high-impact Phase III clinical trials program for FDA approval, and for expanding Prevora’s therapeutic indication in Canada, the UK, Ireland and the EU. The focus of this clinical research is oral inflammation and systemic inflammation. This focus is based on (a) years of observation by Canadian dental professionals that Prevora patients experience rapid and long-lasting improvement in their periodontal health, and (b) growing scientific evidence that improved periodontal health is linked to lower systemic inflammation. Improved management of inflammation is an important goal of medical practitioners and third party payers. If and when approved for this use, Prevora will be a unique, topical approach to lowering inflammation.