Captisol-enabled™ Meloxicam is an intravenous (IV) and intramuscular (IM) version of meloxicam specifically formulated to provide an option for hospital patients suffering from acute post-surgery, trauma and cancer pain following use of IV/IM NSAIDs and in place of or delaying use of IV/IM opioids, which put patients at risk for addiction, respiratory depression, sedation and constipation. Mobic (meloxicam) is currently only available in an oral formulation. Captisol-enabled™ Meloxicam is expected to benefit from the American Society of Anesthesiologists recommendations for a “multi-modal” approach to post-surgical pain. SEDOR Pharmaceuticals is preparing for Phase I studies.
Captisol is Ligand Pharmaceuticals’ patent-protected, chemically modified cyclodextrin that has a chemical structure that was specifically engineered to maximize administration safety while improving solubility, stability and bioavailability of active pharmaceutical ingredients (APIs).
Given the well-established contribution of Captisol to the stability and solubility of APIs, it has been an integral part of New Drug Approval submissions for a number of established global companies in the pharmaceutical industry. Captisol has enabled the development of life-saving medicines in a variety of therapy areas including antifungals, CNS disorders, cardiovascular, and oncology. Extensive preclinical and clinical safety studies have been performed relating to Captisol and indicate that it is safe when administered parenterally, orally and in other routes of administration, and that it does not exhibit toxicities commonly associated with other cyclodextrins. Ligand maintains a large safety database for Captisol within Type IV and V Drug Master Files submitted to the FDA that contain over 200 clinical and safety studies, which Ligand’s license partners can reference for their development efforts with new Captisol-enabled medicines. There are more than 45 Captisol-enabled products currently in development.
Captisol’s broad intellectual property estate includes issued patents in over 60 countries with a potential patent term to 2033.
For more information, visit www.captisol.com.