Baudax Bio is a pharmaceutical company focused on developing and commercializing innovative products for patients in acute care settings. We are committed to bringing clinically meaningful therapeutic options to patients, health care providers, and payers, such as ANJESO® (meloxicam) injection, which was approved by the U.S. Food and Drug Administration (FDA) in February 2020. ANJESO is indicated for use in adults for the management of moderate to severe pain, alone or in combination with non-NSAID analgesics. Because of delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. We believe we can create value for healthcare providers, patients and shareholders through our portfolio of products, which also includes a robust pipeline of product candidates. In addition, we continue to evaluate acquisition and licensing opportunities which align with our core acute care focus.
Our first commercialized product, ANJESO, is a proprietary intravenous (IV) form of meloxicam, a long-acting preferential COX-2 inhibitor. ANJESO was granted FDA approval based on data from three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other safety studies for the management of moderate to severe pain. Overall, the total New Drug Application (NDA) program included over 1,400 patients. Preoperative use of ANJESO was evaluated in two Phase IIIb clinical trials to assess opioid consumption, pain intensity and length of hospital stay with associated pharmacoeconomic parameters. The results from these Phase IIIb trials demonstrated that ANJESO-treated patients had significantly lower opioid consumption and reduced healthcare resource utilization.
We believe that ANJESO compares favorably to other non-opioid therapies in duration andextent of pain relief in addition to being well tolerated by patients in clinical trials. ANJESO, as a non-opioid product, could overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, excessive nausea and vomiting, constipation, as well having no addiction potential. We believe it has the potential to be an important part of a multimodal analgesia (MMA) approach for patients in surgical pain settings and help clinicians fulfill the American Society of Anesthesiologists guidelines for acute pain management.
Our pipeline of investigational candidates includes early and mid-stage product candidates, including two novel neuromuscular blocking agents (NMBAs) and a related proprietary chemical reversal agent, and Dex-IN, a proprietary intranasal formulation of dexmedetomidine, a selective alpha-2 adrenergic agonist that has demonstrated sedative, analgesic and anxiolytic properties.