By Heron Therapeutics, a leading biotechnology company, saw a considerable boost in its shares, increasing by 15% to $2.53, following the approval of its supplemental new drug application by the U.S. Food and Drug Administration (FDA). This approval allows for the expanded use of Zynrelef extended-release solution in various soft tissue and orthopedic surgical procedures, excluding those that involve direct exposure to articular cartilage.
Previously, Zynrelef had been granted approval for use in foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults. However, with the recent approval, an estimated 13 million procedures annually will now fall under the expanded indication for Zynrelef, representing an impressive 86% increase compared to the previous indicated procedures.
The labeling expansion for Zynrelef was obtained through successful studies conducted by Heron on cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty. These new clinical trials did not identify any unique safety issues, and the blood concentrations of bupivacaine and meloxicam remained consistent with previous experiences after using Zynrelef.
Having initially gained FDA approval in May 2021, Zynrelef further solidified its position in the market with the approval of its first supplemental NDA for an expanded label in December 2021.
- Chris Wack
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