Flexion is committed to developing novel, local therapies for the treatment of musculoskeletal conditions, and making them available to patients as quickly and safely as possible. Flexion does not, however, currently have a program to provide individual patient expanded access to its investigational drugs pursuant to section 561(b) of the Federal Food, Drug, and Cosmetic Act (FDCA). In some instances, patients seeking to access Flexion’s investigational drugs may be able to do so by participating in ongoing clinical trials, if they meet specified eligibility criteria. For more information about ongoing clinical trials studying Flexion investigational products, please visit Clinical Trials and Associated Publications or our registry pages at ClinicalTrials.gov.
What are the procedures for making requests for individual patient expanded access to Flexion investigational drugs and how do I contact Flexion to make such requests or to ask questions?
Because Flexion does not currently have a program offering individual patient expanded access to its investigational drugs under FDCA section 561(b), we have not established procedures for making such requests. Patients or medical professionals seeking additional information may contact 781-305-7135.
What criteria are used to decide who gets access to investigational drugs?
Because Flexion does not currently have a program offering individual patient expanded access to its investigational drugs, we have not established criteria for evaluating such requests.
Individual patients seeking to access Flexion’s investigational drugs may be able to do so by participating in ongoing clinical trials. Whether or not a patient is eligible to enroll in any of Flexion’s clinical trials depends on a number of factors, including the specific requirements of each trial and enrollment status. For more information about Flexion’s clinical trials, visit Clinical Trials and Associated Publications or our registry pages at ClinicalTrials.gov.
How long does it take Flexion to respond to requests for individual patient expanded access to Flexion investigational drugs?
All responses to requests for individual patient expanded access to Flexion’s investigational drugs will state that Flexion does not have a program offering an individual patient expanded access program at this time. Flexion commits to responding to requests within three (3) business days of receipt.
