Specialty pharmaceutical company Baudax Bio Inc. (BXRX:NASDAQ), which is engaged in the development of therapeutics for acute care settings, yesterday announced that "the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ANJESO™ (meloxicam injection), which is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics."
Gerri Henwood, President and CEO of Baudax Bio commented, "The approval of ANJESO marks a major advancement in the treatment landscape for managing moderate to severe pain...With our nation currently in the midst of a national opioid epidemic, we are thrilled to be able to offer a novel, non-opioid therapeutic option with the potential to meaningfully impact the acute pain treatment paradigm. We expect to make ANJESO available to physicians and patients in late April or early May 2020."
The company's Chief Medical Officer Stewart McCallum, M.D. remarked, "The safety and efficacy of ANJESO have been well-established through several mid- and late-stage clinical studies...Moreover, data from our Phase III safety trial demonstrated that ANJESO is well tolerated and impacted opioid consumption compared to placebo, further highlighting its value to patients, providers and health systems."
Dr. Keith Candiotti chair of the Department of Anesthesiology, Perioperative Medicine and Pain Management at the University of Miami added, "The approval of ANJESO marks an important achievement for the medical community given the unmet need for non-opioid options in the pain treatment landscape...ANJESO has the potential to serve as a meaningfully differentiated analgesic alternative."
The company advised that ANJESO is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics. The firm explained that "ANJESO™ (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis."
Baudax expects that ANJESO will be available in the U.S. in late April or early May 2020. The firm noted that ANJESO has already been studied in several comprehensive Phase 3 clinical trials studying the safety and efficacy of use following Bunionectomy and Abdominoplasty surgeries and as well as other major surgical procedures including total hip and knee replacements, spinal, GI, hernia repair, and gynecologic surgeries.
Baudax Bio is based in Malvern, PA and is a specialty pharmaceutical company that focuses on developing therapeutics for acute care settings. The firms indicates that its lead drug ANJESO (IV meloxicam) is a non-opioid which has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics without having addictive qualities while maintaining meaningful analgesic effects for relief of pain.
Baudax Bio has a market capitalization of around $75.5 million with approximately 9.436 million shares outstanding and a short interest of about 9.0%. BXRX shares opened greater than 23% higher today at $9.85 (+$1.851, +23.14%) over yesterday's $7.999 closing price and reached a new intraday 52-week high price this morning of $10.14. The stock has traded today between $8.66 and $10.14 per share and is currently trading at $8.965 (+$0.966, +12.08%).[NLINSERT]
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