Abstract: Pharmaceutical compositions of colchicine for once-daily oral administration are provided for use in the treatment of chronic inflammation, including inflammation arising after COVID-19 vaccination and/or COVID-19 infection (Long COVID). The formulations comprise, in some embodiments, an immediate-release component and/or a sustained-release component, which is tailored to achieve a desired pharmacokinetic profile suitable for long-term anti-inflammatory therapy. The disclosed compositions are designed to reduce systemic levels of key inflammatory biomarkers, such as high-sensitivity C-reactive protein (hs-CRP), C-reactive protein (CRP), interleukin-1 (IL-1), interleukin-1? (IL-1?), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-?), and myeloperoxidase (MPO), and to alleviate clinical manifestations of persistent inflammation, including vaccine-associated myocarditis, pericarditis, or other inflammatory sequelae.

Abstract: Pharmaceutical compositions of colchicine for oral administration are provided for use in the treatment or prevention of atherosclerotic cardiovascular disease. The compositions comprise a sustained-release component, an immediate-release component, or a combination thereof, which are selectively adjustable and deliver colchicine according to a predetermined or desired release profile. The disclosed compositions and methods are designed to reduce atherosclerotic plaque, including reducing total plaque burden, and influencing plaque composition, such as non-calcified, fibrous, fibro-fatty, and calcified plaque, through targeted inhibition of vascular inflammation. In certain embodiments, administration of colchicine results in measurable changes in plaque volume and/or composition as assessed by imaging modalities, including coronary computed tomography angiography (CCTA) or intravascular ultrasound (IVUS).

Abstract: Pharmaceutical compositions of colchicine for once-a-day oral administration are provided. The compositions comprise a combination pill which includes (a) a therapeutically effective amount of a composition comprising no more than about 0.6 total mg of colchicine, (b) an amount of a second compound, said second compound being a colchicine-compatible statin; and (c) an amount of a third compound, said third compound being at least one of: (i) a colchicine-compatible SGLT2 inhibitor; and/or (ii) a colchicine-compatible GLP-1 receptor agonist colchicine-compatible; wherein said first compound, said second compound, and said third compound are administered together in the pill with a pharmaceutically acceptable carrier. Methods of treating or reducing a risk of both a cardiovascular event and high blood sugar levels in mammalian subjects comprising the administration of the novel compositions disclosed herein are also provided.

Abstract: Use of colchicine to inhibit tumor growth and metastases in mammalian subjects comprising the administration of the compositions and formulations are provided. The described colchicine compositions and formulations include rapid release, sustained release, and multi-modal release compositions and formulations suitable for alone or in combination with additional pharmaceutically active agents useful in treating tumor growth and metastases.

Abstract: Use of colchicine to inhibit tumor growth and metastases in mammalian subjects comprising the administration of the compositions and formulations are provided. The described colchicine compositions and formulations include rapid release, sustained release, and multi-modal release compositions and formulations suitable for alone or in combination with additional pharmaceutically active agents useful in treating tumor growth and metastases.

Abstract: Use of colchicine to inhibit tumor growth and metastases in mammalian subjects comprising the administration of the compositions and formulations are provided. The described colchicine compositions and formulations include rapid release, sustained release, and multi-modal release compositions and formulations suitable for alone or in combination with additional pharmaceutically active agents useful in treating tumor growth and metastases.

Abstract: Use of colchicine to inhibit tumor growth and metastases in mammalian subjects comprising the administration of the compositions and formulations are provided. The described colchicine compositions and formulations include sustained release, and multimodal release compositions and formulations suitable for alone or in combination with additional pharmaceutically active agents useful in treating tumor growth and metastases.

Abstract: Use of colchicine to inhibit tumor growth and metastases in mammalian subjects comprising the administration of the compositions and formulations are provided. The described colchicine compositions and formulations include sustained release, and multimodal release compositions and formulations suitable for alone or in combination with additional pharmaceutically active agents useful in treating tumor growth and metastases.