Heron's new non opioid painkillers extended US review period by 3 months

Heron therapeutics is a commercial biotech company focused on developing best in class drugs to meet some of the most important unmet medical needs Recently, the company announced that the U.S Food and Drug Administration (FDA) has extended the review period of new non opioid painkiller htx-011 (bupivacaine / meloxicam) new drug application (NDA) for postoperative pain management by three months The target date of the new PDUFA is June 26, 2020 Previously, FDA issued a complete response letter (CRL) on April 30, 2019 for NDA of htx-011, covering chemical, manufacturing and control (CMC) and non clinical information Heron said that the contract manufacturing plant used to manufacture htx-011 had been re inspected by FDA and no form 483 had been issued, and FDA inspectors recommended approval of the plant Heron was not informed of any other manufacturing problems There are no clinical efficacy or safety issues in CRL Barry quart, President and CEO of heron, said: "although it is disappointing that the re submitted htx-011 NDA review time has been extended for three months, FDA said that it will try to complete the work in the shortest time We are satisfied with the positive results of FDA's re inspection of htx-011 contract manufacturing plants, which is an important factor in CRL " Htx-011 is a long-term sustained-release preparation, which is composed of bupivacaine and meloxicam Htx-011 is the first and only dual effect fixed dose combination product, which is specially used for the treatment of postoperative pain and inflammation by single administration at the operation site The drug is developed by Heron's proprietary biochronomer drug delivery technology It provides excellent pain relief by directly providing sustained levels of powerful anesthetics and local anti-inflammatory drugs to the injured tissue, while reducing the demand for systemic (systemic) pain drugs (such as opioids), which have harmful side effects, abuse and addiction Risk In the United States, Heron company submitted the new drug application (NDA) of htx-011 to FDA in October 2018, and FDA accepted the NDA in December 2018 and granted priority review On April 30, 2019, FDA sent a complete response letter (CRL) for NDA of htx-011, involving chemical, manufacturing and control, and non clinical information No issues related to clinical efficacy or safety were found Heron resubmitted the NDA of htx-011 to FDA in September 2019, and the latest PDUFA target date is June 26, 2020 In the European Union, the marketing authorization application (MAA) of htx-011 was accepted by the European Drug Administration (EMA) in March 2019 and reviewed according to the centralized procedure The European Commission (EC) is expected to make a final review decision in the first half of 2020 Biochronomer drug delivery technology (photo source: Heron therapeutics website) The NDA and MAA of htx-011 included data from five phase II and two phase III clinical studies, and included more than 1000 patients who underwent five different surgeries (hernia repair, abdominal wall plasty, excision of bursitis hallucis, total knee arthroplasty and thoracoplasty) Data showed that htx-011 significantly reduced pain intensity and demand for opioids within 72 hours after surgery compared to placebo or bupivacaine (standard care) It is worth mentioning that htx-011 is the first and only non opioid, long-acting local anaesthetic in phase III clinical study that significantly reduces severe pain and significantly reduces the proportion of patients receiving opioid treatment within 72 hours after surgery compared with bupivacaine solution, a standard nursing drug The overall safety of htx-011 was similar to that of bupivacaine solution, and there was no toxicity related to meloxicam Richard, chief medical officer, St Pancras clinical research, chief consultant, pain medicine, London clinic Professor Langford previously said: "improving postoperative pain management is still an unmet demand in Europe and other countries Too many patients still report unacceptable postoperative pain and opioid side effects, which lead to delayed discharge and rehabilitation, increased risk of complications and poor overall treatment results Through continuous and effective pain management, especially in the first few days after surgery, there is a need for easy-to-use and meaningful treatment options for patients In my opinion, htx-011 shows a great prospect in postoperative pain management, and it is possible to change the treatment mode of postoperative pain in European practice "