Heron Therapeutics announced the submission of a supplemental New Drug Application, sNDA, for ZYNRELEF extended-release solution to support the proposed indication for greatly expanded use of ZYNRELEF in soft tissue and orthopedic surgical procedures and a newly passed congressional bill that is anticipated to provide separate reimbursement outside of the packaged surgical payment for ZYNRELEF for almost 3 years. "Submission of this sNDA is designed to further expand ZYNRELEF’s indication for use in soft tissue and orthopedic procedures, which would double the current target surgical procedures to 14 million. The combination of the existing Centers for Medicare and Medicaid Services, CMS, pass-through payments with the new legislation providing separate payments for ZYNRELEF in the outpatient setting of care through December 31, 2027 will provide for more than 4 years of separate reimbursement payments after the 10-month anticipated action date for this sNDA," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "Expanding the indicated surgical procedures and gaining almost three additional years of separate payments from CMS is anticipated to significantly accelerate uptake of ZYNRELEF in large hospital systems, and allow many more patients to benefit from superior pain management over 72 hours with a reduced need for opioids."
Published first on TheFly
See today’s best-performing stocks on TipRanks >>
Read More on HRTX:
