Non-opioid painkillers! The US FDA approved the first once-daily intravenous analgesic Anjeso (meloxicam) to treat moderate to severe pain!

February 22, 2020 / BIOON / -- baudax bio is a professional pharmaceutical company focusing on acute care and treatment Recently, the company announced that the U.S Food and Drug Administration (FDA) has approved the injection of non opioid painkillers - anjeso (meloxicam, meloxicam), which can be used alone or in combination with other non NSAID painkillers for the treatment of moderate to severe pain It is worth mentioning that anjeso is the first and only approved intravenous analgesic once a day Baudax bio has planned to bring anjeso to the U.S market by the end of April or early May 2020 In terms of medication, anjeso was given by intravenous (IV) injection once a day "The approval of anjeso marks significant progress in the treatment of moderate to severe pain," said Gerri henwood, President and CEO of baumax bio At present, the United States is in the midst of a national opium crisis, and we are pleased to be able to provide a novel non opioid drug treatment program with the potential to have a meaningful impact on acute pain treatment models " Anjeso is the only approved 24-hour intravenous (IV) cox-2-biased NSAID that can be administered once a day The active component of anjeso is meloxicam, a long-acting, cox-2-biased inhibitor with analgesic, anti-inflammatory and antipyretic effects, which are believed to be related to the inhibition of cyclooxygenase-2 pathway (COX-2) and subsequent reduction of prostaglandin biosynthesis Meloxicam has been sold by Boehringer Ingelheim as an oral preparation Mobic since the 1990s Mobic is used to treat the symptoms of osteoarthritis and rheumatoid arthritis Oral meloxicam is slow to take effect, mainly due to poor water solubility, and has not been approved for the treatment of acute pain Meloxicam oral preparation has a long absorption time, and the maximum plasma concentration (Tmax) time observed is about 5-6 hours after oral administration, which is consistent with its poor water solubility Baudax bio's proprietary meloxicam injection product, which utilizes Alkermes nacrimic technology, provides meloxicam with faster onset, so as to provide rapid and sustained treatment of acute pain through intravenous (IV) or muscular (IM) delivery At present, the treatment of acute pain with meloxicam IM is in phase I clinical development This approval is based on the support of two phase III efficacy studies and a double-blind, placebo-controlled phase III safety study The results of these studies, together with the results of four phase II clinical studies and other safety studies, constitute the new drug application (NDA) of anjeso The most common adverse reactions reported in the anjeso treatment group were constipation, elevated gamma glutamyltransferase, and anemia in ≥ 2% of patients with a higher incidence than in the placebo group Stewart McCallum, chief medical officer of baumax bio, said: "the safety and efficacy of anjeso has been fully confirmed by several phase II and phase III clinical studies In addition, data from our phase III safety trial showed that anjeso was well tolerated compared to placebo and had a positive impact on reducing opioid use This further highlights the value of the drug to patients, healthcare providers and health systems " According to Dr Keith candiotti, director of Department of Anesthesiology, perioperative medicine and pain management, University of Miami, the approval of anjeso marks an important achievement in the field of medicine in view of the significant unmet medical needs of non opioid drugs in the field of pain treatment Although traditional opioids have been shown to be effective in pain relief, the related side effects, including sedation and respiratory depression, have prompted doctors to adopt a multimodal approach to the treatment of postoperative pain Because of the 24-hour long-lasting pain relief and the safety comparable to placebo, anjeso has the potential to be a very meaningful and differentiated analgesic treatment option " At present, the market of pain is dominated by opioids Non opioid analgesic products are important tools for patients and doctors to manage pain safely and effectively in a variety of clinical environments Anjeso is a non opioid drug, which can overcome many related problems of conventional prescription opioids, including respiratory inhibition, constipation, excessive nausea and vomiting, avoid addiction and abuse, and maintain significant analgesic effect According to baudax bio, anjeso has great potential as a treatment option for moderate and severe pain in a variety of clinical environments The non opioid analgesic product will help solve the current severe opioid epidemic crisis in the United States after its launch In particular, recently, the FDA advisory committee on narcotic and analgesic products (aadpac) and the drug safety and Risk Management Advisory Committee (dsarm) voted 27:0 against the approval of nktr-181 (oxycodegol, pegylated oxycodone), an opioid painkiller of nektar therapeutics Based on the voting results, nektar therapeutics has decided to withdraw nktr-181's new drug application (NDA) and no longer invest in the project (Bio Valley Com) original source: baumax bio announcements FDA approval of anjeso for the management of moderate to severe pain