New painkillers after surgery! The new non-opioid painkiller HTX-011 was accepted by the FDA and granted priority review

, January 9, 2019 /XINHUA/ -- Heron Therapeutics is a commercial biotech company focused on developing best-in-class drugs to meet some of the most important unfolested medical needs. Recently, the company announced that the U.S. Food and Drug Administration (FDA) has accepted new drug applications for HTX-011 (NDA) and granted priority review eligibility (PRD), with a target date of April 30, 2019 for the Prescription Drug User Charge Act (PDUFA). Previously, the FDA granted HTX-011 fast-track eligibility (FTD) and breakthrough drug eligibility (BTD).
HTX-011 is a long-acting slow-release agent consisting of a fixed dose of local anaesthetic bupicaine and the anti-inflammatory drug meloxicam, used to treat postoperative pain. HTX-011 is the first and only dual-acting fixed-dose combination product designed to treat postoperative pain and inflammation with a single dose at the surgical site. Developed using Heron's proprietary Biochronomer drug delivery technology, the drug provides superior pain relief by providing consistent levels of powerful anesthetics and topical anti-inflammatory drugs directly to tissue damage sites, while reducing the need for systematic (systemic) medications such as opioids, which have harmful side effects, abuse and addiction risks.
HTX-011 NDA, submitted on October 30, 2018, included data from 5 Phase II clinical studies and 2 Phase III clinical studies, and included more than 1,000 patients who underwent 5 different surgical procedures (xenon repair, abdominal wall forming, cystic excision, full knee joint replacement, and breast augmentation). The data showed that within 72 hours of surgery, HTX-011 significantly reduced pain intensity and the need for opioids compared to placebo or ddypaedic acid (standard care).
Fast Track Qualification (FTD), Breakthrough Drug Qualification (BTD), Priority Review Qualification (PRD) are three new drug review channels created by the FDA: (1) FTD is designed to accelerate drug development and rapid review for serious diseases to address critically unsolved medical needs in key areas, and access to FTD for experimental drugs means that pharmaceutical companies can interact more frequently with the FDA during the development phase and may also receive F after submitting new drug applications (NDA). Priority review by the DA; (2) BTD is designed to accelerate the development and review of new drugs used to treat serious or life-threatening diseases and there is preliminary clinical evidence that the drug can substantially improve the condition compared to existing therapeutic drugs; For PRD-approved drugs, the FDA will give an accelerated review and complete the review in six months instead of the standard 10 months.
It is worth noting that HTX-011 is the first and only non-opioid, long-acting local anaesthetic to significantly reduce severe pain and significantly reduce the proportion of patients receiving opioid treatment within 72 hours of surgery compared to the standard care drug Bubikain solution in Phase III clinical studies. The overall safety of HTX-011 is similar to that of Bubicain solutions and has no meloxicon-related toxicity. (Bio Valley)