Expanded Access Program
Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release alternatives to currently approved drugs. Each of Eupraxia's product candidates has the potential to address therapeutic areas with high unmet medical need and strives to provide improved patient benefit by delivering targeted, long-lasting activity with fewer side effects.
Companies engaged in drug development routinely receive inquiries from physicians and patients looking to access investigational drugs prior to their receiving regulatory approval. Expanded access programs are typically geared toward patients with serious or immediately life-threatening diseases who have exhausted their other treatment options.
At this time, Eupraxia does not offer an expanded access program. The Company’s investigational drugs are currently only available through participation in a clinical trial. Clinical trials are controlled studies in humans that are designed to determine if a drug is both safe and effective. Management believes that testing drugs in a closely controlled clinical setting is the most expeditious way to make these determinations and then use the supporting data to apply for marketing authorization. Ultimately, applying for and receiving marketing authorization in jurisdictions globally is the quickest and safest way to ensure a drug is widely available and of benefit to the largest group of patients possible. Eupraxia intends to use the mechanisms made available by regulators to expedite completion of its clinical programs and accelerate the review of any resulting data and/or decisions pertaining to marketing authorization.
Physicians and patients that wish to learn more about Eupraxia’s clinical programs should visit the clinicaltrials.gov website.
Eupraxia reserves the right to modify this policy at any point in the future, including as additional safety and efficacy data becomes available.