Heron Therapeutics’ Prior Approval Supplement application for ZYNRELEF’s Vial Access Needle has been accepted by the FDA, with a PDUFA date set for September 23, 2024.
Key points:
- The new Vial Access Needle (VAN) could reduce ZYNRELEF’s withdrawal time from up to 3 minutes to 20-45 seconds.
- If approved, the VAN is expected to be available in Q4 2024, potentially enhancing ZYNRELEF’s adoption and safe use.
- Heron’s partnership with CrossLink Life Sciences is set to add ~650 representatives to promote ZYNRELEF by year-end.
Market estimate: The global postoperative pain management market was valued at $36.7 billion in 2022 and is expected to reach $45.1 billion by 2027, according to MarketsandMarkets.
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Tuesday Heron Therapeutics (Nasdaq: HRTX) announced that the U.S. Food and Drug Administration (FDA) has accepted its Prior Approval Supplement (PAS) application for a new Vial Access Needle (VAN) for ZYNRELEF®. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of September 23, 2024, signaling a potentially swift review process.
ZYNRELEF, a dual-acting local anesthetic, has been making waves in the postoperative pain management field since its initial FDA approval in May 2021. The proposed VAN upgrade could significantly enhance its usability and adoption in clinical settings.
Craig Collard, Chief Executive Officer at Heron, expressed optimism about the development: “The acknowledgement of the VAN submission and corresponding designation of a four-month review for ZYNRELEF is exciting, and we look forward to working with the FDA during the application review process.”
The new VAN design promises to streamline the preparation process for ZYNRELEF dramatically. If approved, it could reduce the withdrawal time from the current up to three minutes to a mere 20-45 seconds. This improvement not only saves valuable time in surgical settings but also potentially enhances the safe use of the medication.
Heron is positioning this upgrade as a game-changer for ZYNRELEF’s adoption. The user-friendly “container-like” design of the VAN is expected to simplify aseptic preparation, potentially leading to increased use among healthcare providers.
In parallel with this regulatory progress, Heron is bolstering its marketing efforts. The company’s partnership with CrossLink Life Sciences is set to add approximately 650 representatives to promote ZYNRELEF by year-end. This expanded sales force is expected to play a crucial role in launching the VAN to a broad base of orthopedic surgeons across the country.
The global postoperative pain management market is projected to reach $45.1 billion by 2027, according to MarketsandMarkets. ZYNRELEF, with its potential for easier administration, could be capture a significant share of this sizable market.
ZYNRELEF’s unique selling point is its ability to provide extended-release pain relief for up to 72 hours post-surgery, potentially reducing the need for opioids. The medication has shown promising results in Phase 3 studies, demonstrating significantly reduced pain and increased proportion of patients requiring no opioids compared to the current standard-of-care local anesthetic.
If approved, the new VAN is expected to be available for use in the fourth quarter of this year, potentially marking a significant milestone in Heron’s efforts to revolutionize postoperative pain management.
