Heron Therapeutics Resubmits New Drug Application to FDA for HTX-011 for Treatment of Postoperative Pain
SAN DIEGO, November 13, 2020 / PRNewswire / – Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing the best treatments to meet some of the most important unmet needs of patients, today announced that the New Drug Application (NDA) has been resubmitted to the United States Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain.
The NDA for HTX-011 was resubmitted based on the results and final minutes of a Type A end-of-review meeting with the FDA in September, which was conducted to seek clarification on the information needed to process the Full Response Letter (CRL) issued by the FDA in June 2020. The CRL has stated that the FDA is unable to approve the NDA in its current form due to the need for information not additional clinics. There are four non-clinical issues in CSF, three relate to confirmation of excipient exposure in preclinical reproductive toxicology studies, and the fourth relates to changing the release specification by manufacturing the allowable level of an impurity on the body. basis of animal toxicological coverage. Since receiving CSF, Heron has generated data showing that peak plasma levels (Cmax) of excipients in reproductive toxicology studies are> 50 to> 200 times higher than levels seen in patients receiving CSF. highest dose of HTX-011. These results validate the animal studies previously submitted. At the Type A end-of-review meeting in September, the FDA agreed to the change in manufacturing specifications proposed by Heron to address its concerns. The FDA indicated at the Type A end-of-review meeting that the submission will be classified as a new Class 2 submission, which means that the FDA can take up to 6 months to review the new information included in the submission. new submission of NDA.
“We are delighted to have resubmitted the NDA for HTX-011, which we believe fully responds to the CRL based on guidance from the FDA,” said Barry Quart, Pharm.D., President and chief from the direction of Heron. “In our new submission, we have provided compelling evidence addressing the issues identified in the CRL which should form the basis for the approval of NDA HTX-011. Heron remains committed to bringing HTX-011 to patients and we look forward to working with the FDA to achieve this goal. “
About HTX-011 for postoperative pain (ZYNRELEFMT in the European Union and the European Economic Area)
HTX-011, an investigational non-opioid analgesic, is a fixed-dose, dual-action combination of the local anesthetic bupivacaine with a low dose of meloxicam, a non-steroidal anti-inflammatory drug. It is the first and only sustained-release local anesthetic to demonstrate in phase 3 studies a significant reduction in pain and opioid use for 72 hours compared to bupivacaine solution, the local anesthetic. current standard for postoperative pain control. The FDA granted the breakthrough therapy designation to HTX-011 and the NDA received the priority review designation. A CRL was received from the FDA regarding the NDA for HTX-011 in june 2020 regarding non-clinical information. No safety or clinical efficacy issues, and no chemistry, manufacturing and control issues were identified. Heron’s New Drug Submission (NDP) for HTX-011 for the management of postoperative pain has been accepted by Health Canada. Heron endeavors to respond to a list of questions received from Health Canada in july 2020. In September 2020, the European Commission (EC) has granted marketing authorization for ZYNRELEF (also known as HTX-011) for the treatment of postoperative somatic pain in small to medium-sized surgical wounds in adults. The centralized EC marketing authorization is valid for the 27 member countries of the European Union and the other countries of the European Economic Area.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing the best treatments to meet some of the most important needs of unmet patients. Heron is developing new patient-centric solutions that apply its innovative science and technologies to pharmacological agents already approved for patients with pain or cancer. For more information visit www.herontx.com.
This press release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on the expectations and assumptions of management as of the date of release. this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, those associated with: whether the FDA approves the NDA for HTX-011; the timing of the commercial launch of HTX-011 in the United States; the timing of the commercial launch of ZYNRELEF in Europe; Health Canada’s NDS review process timeline for HTX-011; whether Health Canada issues a notice of compliance for the NDS for HTX-011; the extent of the impact of the ongoing COVID-19 pandemic on our business; and other risks and uncertainties identified in documents filed by the Company with the United States Securities and Exchange Commission. Forward-looking statements reflect our analysis only as of the date indicated, and Heron assumes no obligation to update or revise such statements, except as required by law.
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