The U.S. Food and Drug Administration approved Heron Therapeutics Inc.’s Zynrelef (bupivacaine and meloxicam) extended-release solution for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.
Placebo response is one of the most significant challenges faced by drug developers who are investigating new pain medications. According to a review of published chronic neuropathic pain trials, placebo responses have increased in magnitude over time, making it even more difficult to definitively demonstrate treatment advantage. Research has also shown that up to 60 percent of study participants may experience placebo-related analgesic responses and that these responses may be persistent.
Findings from a Phase III long-term extension study show a once-daily therapy consisting of relugolix with estradiol and norethindrone acetate leads to clinically meaningful reductions in menstrual pain and non-menstrual pelvic pain over one year in women with endometriosis.
The U.S. Federal Trade Commission filed a lawsuit against Endo Pharmaceuticals and Impax Laboratories that alleges a 2017 agreement eliminated competition between the companies for the pain medicine oxymorphone ER.
Skyhawk Therapeutics and Vertex Pharmaceuticals inked a strategic research collaboration and licensing deal focused on developing novel small molecules that modulate RNA splicing.
A dual treatment approach consisting of gemcitabine combined with AB Science’s highly selective tyrosine kinase inhibitor masitinib was associated with significant increases in survival among patients with pancreatic cancer and pain, according to recently announced results from a confirmatory Phase III study.
Heron Therapeutics Inc.’s New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration for HTX-011, an investigational agent for the management of postoperative pain.
O.C Suboxone understands the severity of opioid use disorder and is working to raise awareness on healthier alternatives to treat chronic pain.
Shares of Avenue Therapeutics plunged in trading after the company announced the U.S. Food and Drug Administration rejected the New Drug Application for intravenous tramadol over safety concerns.
Genentech presented new data on Enspryng (satralizumab-mwge), which was approved by the U.S. Food and Drug Administration in mid-August 2020 as a subcutaneous treatment for adults with anti-aquaporin-4 antibody positive neuromyelitis optica spectrum.