20th May 2012
Development and Regulatory status
Apr 19 · EU filing accepted by the EMA. The EMA will review the application via centralised procedure. The eligibility to the centralised procedure for bupivacaine/meloxicam was based on its meeting criteria of a medicinal product constituting a significant scientific innovation. The MAA submission was supported by data from the 7 completed PII and PIII studies .
Apr 19 · FDA issues a complete response letter (CRL) to Heron Therapeutics regarding the New Drug Application (NDA) for bupivacaine/meloxicam for management of post-operative pain. The CRL stated that the US FDA was unable to approve the NDA and requested the company for additional Chemistry Manufacturing and Controls (CMC) and non-clinical information. In review of the NDA, the agency did not identified any issue related to clinical efficacy and safety data. The US FDA did not request any further clinical data from the company. Heron plans to schedule a meeting with the FDA to resolve issues outlined in the CRL .
Dec 18 · Granted priority review in the US .
Oct 18 · Filed in US. The NDA filing is based on the results of 7 completed clinical studies in 5 bony and soft tissue surgical procedures that included over 1,000 patients who received HTX 011 .
HTX-011 is a fixed-dose combination of the local anaesthetic bupivacaine with the nonsteroidal anti-inflammatory drug (NSAID) meloxicam, in a long-acting, extended-release formulation.
Almost 60% of patients experience severe pain in the postoperative period, with a marked negative impact on health related quality of life .
Trial or other data
May 19 · Heron Therapeutics announces that the EPOCH 1 study achieved both primary and key secondary endpoint .
Mar 18 · Top-line data from the two PIII EPOCH 1 and EPOCH 2 trials released. The results from the these trials will support the NDA .
Mar 18 · PIII EPOCH 1 study to evaluate the analgesic efficacy and safety of bupivacaine/meloxicam administered via local administration into the surgical site in subjects undergoing bunionectomy completes (NCT03295721; HTX011-301). The randomised, double-blind, saline placebo- and active-controlled trial enrolled 412 patients in the US .
Jan 18 · PIII EPOCH 2 trial designed to evaluate the efficacy and safety of bupivacaine/meloxicam, applied locally to the surgical site, for postoperative analgesia in patients undergoing unilateral open inguinal herniorrhaphy completes (HTX-011-302; NCT03237481). The primary endpoints were the difference in mean area under the curve (AUC) of pain intensity scores through 72 hours compared with placebo. The randomised, saline placebo and active controlled trial enrolled 418 patients in the US and Belgium .