Heron Therapeutics (HRTX -0.1%) announces the publication of results, online in the Journal of Arthroplasty, from a Phase 2b clinical trial, Study 209, evaluating HTX-011 for postoperative pain relief in patients who have undergone total knee arthroplasty (knee replacement).
HTX-011 showed superior pain reduction compared to
placebo or bupivacaine solution through hours 48 – 72 after surgery.
Also, more patients treated with HTX-011 were ready for discharge at
hours 8, 12 and 24.
HTX-011 is a long-acting, extended-release
formulation of the local anesthetic bupivacaine combined with the
anti-inflammatory agent meloxicam.
The FDA’s action date for its review of the
company’s refiled marketing application is June 26. It received a CRL in
April 2019 in response to its original filing citing the need for
additional non-clinical information. Its applications in Europe and
Canada are under review.
https://seekingalpha.com/news/3580451-herons-htxminus-011-shows-benefit-in-mid-stage-knee-replacement-study
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.