Expanded access policy
DURECT Corporation (DURECT) is committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and lifesaving therapies based on its endogenous epigenetic regulator program. Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational products for the treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561(b) of the Federal Food, Product, and Cosmetic Act for provision of such a product.
After carefully reviewing considerations for expanded access, DURECT has determined that it cannot offer its product candidates for expanded access (sometimes called “Compassionate Use”) at this time. DURECT believes that investigational products should be studied in patients as part of clinical trials designed to obtain data on safety and efficacy. As a general policy, DURECT does not provide investigational product until sufficient preliminary safety and efficacy information has been obtained in clinical trials, typically following Phase 2b investigation.
These clinical trials allow DURECT to generate the safety and efficacy data needed for FDA to determine whether this investigational product should be approved, helping the many patients who could benefit from our therapies. As DURECT keeps conducting clinical trials, it continues to weigh safety and efficacy data. These data will allow DURECT to better determine the risks and benefits of offering our product candidates through expanded access. Based on ongoing trials and new results, DURECT may make updates to this policy in the future.
If you or a family member would like to learn more about DURECT’s clinical trials, we encourage you to work with your physician to see if you could be a candidate for one of our trials. You may also find helpful information regarding DURECT’s clinical trials by visiting www.clinicaltrials.gov. For information on the AHFIRM Clinical Trial - Phase 2b study in subjects with Alcoholic Hepatitis to evaluate saFety and effIcacy of DUR-928 treatMent (AHFIRM) click: https://clinicaltrials.gov/ct2/show/NCT04563026?term=NCT04563026&draw=2&rank=1
If you have questions about DURECT’s expanded access policy please email us at email@example.com.