Today we announced another important milestone in the development of our lead investigational product candidate ATX101. The U.S. Food & Drug Administration has accepted our investigational new drug application, clearing the way for us to initiate a pivotal Phase 2B clinical trial of ATX101 for the treatment of post-surgical pain following total knee replacement surgery. This clinical trial builds on a strong foundation of clinical data from prior exploratory dose-ranging studies that demonstrated ATX101’s potential to transform the pain management paradigm. We are excited for the opportunity to further evaluate ATX101 and plan to enroll 200 trial participants at U.S. sites. We are committed to pioneering ultra-sustained, non-opioid-based analgesic products that aid patient recovery while reducing the costs of these surgeries for patients, physicians and payors alike. Today’s milestone is another key marker on the path to a new drug application to be filed with the FDA. More in today’s press release: https://lnkd.in/eguJ7ViK #clincaltrial #painmanagement #TKA #analgesic #bupivacaine #nonopiod #postsurgicalrecovery #drugdelivery #kneereplacement #orthopedics #orthopedicsurgery
Congratulations, Adam Gridley - hope you guys are doing well.
Big milestone!!
Congratulations to the Allay team!
Fantastic update! Congratulations to the Allay Therapeutics team!
Woohoo! Congratulations to the Allay team!
Great news! Congrats Adam Gridley and Team.
Congratulations, James Su, PhD and Allay Team!
Congratulations, Adam and team!
Congratulations Adam!
Sales Development Rep @ Greenphire
1moBig milestone, congratulations