A message to clinicians from Michael Clayman, MD,
President & Chief Executive Officer
As the COVID-19 pandemic continues to evolve, we are committed to doing everything in our power to help ensure the health, safety and well-being of our patients, customers, employees and their families. With that in mind, in early March we instructed all of our employees to work remotely, and we instructed our customer-facing employees to utilize technology to provide support virtually.
Product Inventory & Supply Chain
We are well positioned to provide ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) in the months ahead. We have at least 10 months of finished goods available in the U.S., and 12 months of active pharmaceutical ingredient (triamcinolone acetonide) available at our manufacturing site.
Clinical Trials
Based on the recent guidance from the U.S. Food and Drug Administration, in March we made the decision to temporarily suspend our active clinical trials to ensure the safety of trial participants and minimize risk to trial integrity from disruptions caused by COVID-19. These include the Phase 1 trial evaluating the safety and tolerability of FX201, our investigational intra-articular gene therapy product candidate, in patients with OA of the knee, and the Phase 2 trial evaluating the efficacy of ZILRETTA in patients with shoulder OA or adhesive capsulitis.
Our Gratitude & Support
All of us at Flexion want to express our deepest thanks and gratitude to the heroes on the front lines in the fight against COVID-19. From our first responders to the brave professionals working in our nation’s hospitals, their selflessness and dedication is awe inspiring. They are true role models, and we will be forever in their debt.
We are all in this together. No matter how big or small, we can all play a part to help others during the pandemic. At Flexion, we are doing what we can to help address the increasing demand for medical supplies. We have contributed personal protection equipment from our Innovation Lab to local hospitals and to the collection effort coordinated by MassBio.
We are continuously assessing the situation and will provide further updates on our business operations and response to the coronavirus as appropriate.
Be well.
