The U.S. Food and Drug Administration has a busy week of possible drug approvals on the regulatory agency’s calendar, including Celgene’s ozanimod for relapsing forms of multiple sclerosis.
Heron Therapeutics Inc. announced positive topline results of a multi-center postoperative pain management study in which 51 patients undergoing total knee arthroplasty surgery received the investigational agent HTX-011 together with a scheduled postoperative regimen of generic, oral analgesics (acetaminophen and celecoxib).
Heron Therapeutics Inc. resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for the commercial-stage biotechnology company’s HTX-011, an investigational agent for the management of postoperative pain.
Heron Therapeutics Inc. announced that the company received a Complete Response Letter from the U.S. Food and Drug Administration on April 30, 2019 regarding the New Drug Application for HTX-011 for the management of postoperative pain.
New York City-based Avenue Therapeutics announced that the company’ Phase III clinical trial of IV tramadol hit its primary endpoint of statistically significant improvement in Sum of Pain Intensity Difference over 48 hours (SPID48) in patients with moderate to moderately severe postoperative pain after bunionectomy surgery.