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Publication Number
US-11364277-B2
Publication Date
2022-06-21
Expiration Date
Abstract
A method for treating ascites patients by administering the peptide drug terlipressin by continuous infusion. The patients include those whose ascites condition has not progressed to hepatorenal syndrome (HRS). Administration may be accomplished with a continuous infusion pump.
Core Innovation
The invention relates to treating ascites due to liver cirrhosis in a non-hepatorenal syndrome (HRS) patient by administering a monotherapy of a continuous infusion of terlipressin or salt thereof. The continuous infusion is given at a dose of about 0.8 mg to about 5.0 mg of terlipressin per day while the patient is not hospitalized, and the ascites is reduced.
The approach also focuses on reducing the accumulation of ascitic fluid in the abdominal cavity of an ascites non-HRS patient. Reducing the accumulation of ascitic fluid improves the ascites, and continuous infusion is used as the dosing mode within the disclosed daily range of about 0.8 mg to about 5.0 mg of terlipressin per day.
The continuous infusion is described as suitable for outpatient use and optionally delivered using an ambulatory infusion pump. The treatment duration ranges from about one day to about 12 months, and additional limitations include that the patient is not administered diuretics during the treatment duration.
Claims Coverage
The document includes two independent claims centered on terlipressin monotherapy delivered as a continuous infusion in non-HRS, non-hospitalized patients with liver-cirrhosis-related ascites, within a shared daily dose range, where ascites is reduced or accumulation is reduced to improve ascites.
Continuous infusion terlipressin monotherapy for non-HRS ascites reduction
A method for treating ascites in a non-HRS patient diagnosed with ascites due to liver cirrhosis by administering a monotherapy of a continuous infusion of terlipressin or salt thereof to the patient, at a continuous infusion dose of about 0.8 mg to about 5.0 mg of terlipressin per day, wherein the patient is not hospitalized, and wherein the ascites in the patient is reduced.
Reducing accumulation of ascitic fluid with continuous infusion terlipressin monotherapy
A method for reducing the accumulation of ascitic fluid in the abdominal cavity in an ascites, non-HRS patient by administering a monotherapy of a continuous infusion of terlipressin or salt thereof to the patient, at a continuous infusion dose of about 0.8 mg to about 5.0 mg of terlipressin per day, wherein the patient is not hospitalized, and wherein reducing the accumulation of ascitic fluid in the abdominal cavity of the patient improves the ascites in the patient.
Overall claim coverage is anchored by two independent methods using terlipressin (or a salt) as monotherapy with a continuous infusion delivered to non-HRS, non-hospitalized patients, at about 0.8 mg to about 5.0 mg terlipressin per day, where the ascites is reduced or where reduced accumulation improves ascites.
Stated Advantages
Reduced frequency of paracentesis.
Decreased ascites burden, including body weight/ascites fluid volume.
Increased urinary sodium excretion.
Improved renal markers including serum creatinine and serum urea.
Correction of hyponatremia (plasma sodium).
Potential MELD improvement.
Possible combination with hepatitis C antiviral medication.
Documented Applications
Outpatient treatment of cirrhosis-associated ascites in patients whose ascites has not progressed to hepatorenal syndrome (HRS), using continuous infusion of terlipressin via a pump to reduce ascites and ascites fluid accumulation.
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