Expanded Access Policy

Strongbridge U.S. Inc. Policy on Expanded Access

Strongbridge U.S. Inc. (Strongbridge) is a biopharmaceutical company committed to connecting patients with new treatments for rare diseases. As part of the drug development process, Strongbridge conducts clinical trials to study the safety and efficacy of its investigational products. The information from these trials is used to support marketing applications submitted to FDA and other regulatory authorities.

Some drug companies may make their investigational drugs available to individual patients through an expanded access program. An expanded access program provides for the use of an investigational drug prior to approval by the FDA outside of the clinical trial setting.

We believe the best way to make our investigational drugs available to individuals is through their participation in one of our ongoing clinical trials.

For more information on Strongbridge’s clinical trials, see https://clinicaltrials.gov. Search for “Strongbridge” or "Cortendo" to find our clinical trials that may currently be recruiting.

If you are a healthcare professional and would like more information on Strongbridge’s investigational products, please contact expandedaccess@strongbridgebio.com. We anticipate that we will acknowledge receipt of emails within 5 business days.

We reserve the right to revise this policy at any time.

© 2018 Strongbridge Biopharma plc
STRONGBRIDGE BIOPHARMA® is a registered trademark of the Strongbridge Biopharma plc. companies, which include Strongbridge Ireland Limited and Strongbridge U.S. Inc.
KEVEYIS® is a registered trademark licensed exclusively in the U.S. to Strongbridge Biopharma plc.
MACRILEN is a trademark of Aeterna Zentaris GmbH, licensed exclusively in the U.S. and Canada to Strongbridge Ireland Limited.
MLR-0010 V13 01/2018

900 Northbrook Drive, Suite 200
Trevose, PA 19053
United States
Phone: +1 610-254-9200
info@strongbridgebio.com

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