Heron Therapeutics, Inc. has announced that the FDA acknowledged the receipt of the company's Prior Approval Supplement (PAS) application for ZYNRELEF (bupivacaine and meloxicam) extended-release solution VAN.

If approved, the introduction of the VAN will replace the current vented vial spike and has the potential to simplify aseptic preparation, while also significantly reducing ZYNRELEF's withdrawal time from up to three minutes down to between twenty and forty-five seconds.

The user-friendly "container-like" design of the VAN may enhance the safe use of ZYNRELEF, increase adoption, and improve the preparation process. If approved, the VAN is expected to be available for use in the fourth quarter of this year.

In addition to the anticipated launch of the VAN, the national rollout of the CrossLink Life Sciences, LLC (CrossLink) partnership continues to make progress and is expected to add ~650 representatives to the promotion of ZYNRELEF by year-end. The company anticipates that this partnership will be instrumental in successfully launching the VAN to a large base of orthopedic surgeons across the country.

"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," said Craig Collard, Chief Executive Officer at Heron.

"With the continued integration of CrossLink and the launch of the VAN, we are optimistic about the potential for more accounts to adopt ZYNRELEF as an essential part of their surgical procedures, “Collard added.