Baudax Bio is a specialty pharmaceutical company focused on developing and commercializing innovative products for patients in acute care settings. Baudax Bio was spun-out from Recro Pharma, Inc (REPH) in 2019 when Recro Pharma, Inc. separated its Acute Care Division from its Contract Drug Manufacturing Organization that together were “Recro Pharma”. We are committed to bringing clinically meaningful therapeutic options to patients, health care providers, and payers, such as our lead product candidate, injectable meloxicam. We believe we can create value for patients and shareholders through our robust pipeline of product candidates. In addition, we continue to evaluate acquisition and licensing opportunities which align with our core acute care focus.
Our lead product candidate is a proprietary IV injectable form of meloxicam, a long-acting preferential COX-2 inhibitor. IV meloxicam has successfully completed 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. We received two Complete Response Letters (CRL) for IV Meloxicam which we appealed to the first level and our appeal was granted. We are preparing a refiling of the NDA with a comprehensive response to the letter. Revised prescribing information will be included, along with the required update to safety summaries since the last filing.
We believe that IV meloxicam compares favorably to competitive non-opioid therapies in onset of pain relief, duration of pain relief, extent of pain relief in addition to being well tolerated by patients in clinical trials. IV meloxicam, 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 can be an important part of a multimodal analgesia (MMA) approach for patients in surgical pain settings.
Our pipeline also includes other early-stage product candidates, including two novel neuromuscular blocker agents (NMBs) 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.