Expanded Access Program
Xenon Pharmaceuticals is committed to developing innovative, safe and effective therapeutics to improve the lives of patients with neurological disorders, and we recognize the value of collaborating with patients, families, advocacy organizations, physicians and other healthcare professionals, researchers and regulatory authorities to accomplish this goal.
We understand that patients, families and physicians may be interested in accessing Xenon’s investigational drugs prior to regulatory approval through an expanded access program (sometimes referred to as “compassionate use program”). Expanded access programs allow patients with serious or immediately life-threatening diseases, who have exhausted all other treatment options, to access an investigational drug outside of a clinical trial, and prior to regulatory approval.
At this time, Xenon does not currently have an expanded access program that makes our investigational drugs available to patients other than by participating in one of our clinical trials. Clinical trials are controlled studies in humans designed to establish if an investigational drug is safe and effective. Xenon believes clinical trials are the most appropriate way to efficiently collect all data necessary to seek regulatory approvals. At this time, Xenon does not have sufficient information about the potential risks and benefits of our investigational drugs to ensure that patient access outside the regulated clinical trial process does not delay nor compromise our clinical trials and, ultimately, broad availability to the entire patient community.
Physicians, patients and caregivers interested in learning more about Xenon’s ongoing clinical trials can find additional information on clinicaltrials.gov.
Xenon may revise this policy at any time. For any additional questions, please contact us at firstname.lastname@example.org.