Captisol-enabled™ Budesonide + Azelastine is a fixed-dose combination of a corticosteroid and antihistamine in an intranasal (IN) formulation for the treatment of allergic rhinitis. Compared with sequential separate intranasal dosing of these patients with similar agents, Captisol-enabled™ Budesonide + Azelastine holds potential for improved compliance in once-daily and twice-daily dosing. SEDOR Pharmaceuticals is preparing for Phase I studies in the United States following successful Phase II proof-of-concept studies in Canada.
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.