A Phase 2B, Randomized, Double Blind, Active Comparator, Multicenter, Safety, and Efficacy Trial of ATX-101 in Subjects Undergoing Total Knee Arthroplasty
Latest Information Update: 05 Dec 2024
Price :
$35 *
At a glance
- Drugs Bupivacaine (Primary) ; Bupivacaine
- Indications Postoperative pain
- Focus Pharmacokinetics
- Acronyms SPARK
- Sponsors Allay Therapeutics
- 04 Dec 2024 According to Allay Therapeutics Media Release, company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for its lead investigational product ATX101 for treatment of postsurgical pain following TKA procedures in adults. This Breakthrough Therapy designation was granted based on clinical data from a Phase 2 exploratory dose-ranging trial for the treatment of Post-Surgical Pain following Total Knee Arthroplasty (TKA), or replacement.
- 26 Jun 2024 Status changed from active, no longer recruiting to discontinued.
- 11 Apr 2024 According to an Allay Therapeutics media release, Prof. Hemant Pandit is leading investigator in this trial.