Nasal administration of agents for the treatment of gastroparesis

Abstract

The present invention is directed to a method for the treatment of gastroparesis by the use of metoclopramide nasal formulation.

What is claimed is:  
     
         1 . A method for treating or reducing the symptoms of gastroparesis in a patient comprising the step of: 
 administering metoclopramide or a pharmaceutically acceptable salt thereof to a patient in need of gastroparesis treatment, wherein said metoclopramide is in a pharmaceutically acceptable nasal formulation and administered intranasally in a therapeutically effective amount so that one or more symptom of gastroparesis is reduced.    
     
     
         2 . The method of  claim 1  wherein said daily dosage is between about 40 mg/day to about 160 mg/day.  
     
     
         3 . The method of  claim 2  wherein said daily dosage is between about 40 mg/day to about 80 mg/day.  
     
     
         4 . The method of  claim 2  wherein said daily dosage is about 40 mg/day.  
     
     
         5 . The method of  claim 2  wherein said daily dosage is about 80 mg/day.  
     
     
         6 . The method of  claim 1  wherein said daily dosage is divided into 3 or 4 equal smaller doses and administered at equally spaced intervals within 24 hours.  
     
     
         7 . The method of  claim 1  wherein said daily dosage is divided into 3 or 4 equal smaller doses and administered before meals and before bedtime.  
     
     
         8 . The method of  claim 6  or  7  wherein the smaller doses are about 10 mg each.  
     
     
         9 . The method of  claim 6  or  7  wherein the smaller doses are about 20 mg each.  
     
     
         10 . The method of  claim 1  wherein said daily dosage is between about 0.1 mg/kg to about 2.5 mg/kg.  
     
     
         11 . The method of  claim 10 , wherein said daily dosage is between about 0.6 mg/kg to about 1.2 mg/kg.  
     
     
         12 . The method of  claim 1  wherein the metoclopramide or pharmaceutically acceptable salt thereof is in an aqueous-based carrier.  
     
     
         13 . The method of  claim 1  wherein the metoclopramide or pharmaceutically acceptable salt thereof is in a sustained release formulation.  
     
     
         14 . The method of  claim 1  wherein the metoclopramide or pharmaceutically acceptable salt thereof is co-administered with one or more additional drugs.  
     
     
         15 . The method of  claim 1  wherein said dosage is administered for treating gastroparesis caused by diabetes.  
     
     
         16 . The method of  claim 15  wherein said diabetes is selected from the group consisting of type 1 diabetes and type 2 diabetes.  
     
     
         17 . The method of  claim 1  wherein said dosage is administered for treating gastroparesis caused by diabetes (including type 1 and type 2 diabetes), postviral syndromes, anorexia nervosa, surgery on the on the stomach or vagus nerve, medications, particularly anticholinergics and narcotics which slow contractions in the intestine, gastroesophageal reflux disease, smooth muscle disorders such as amyloidosis and scleroderma, nervous system diseases (including abdominal migraine and Parkinson's disease), or metabolic disorders (including hypothyroidism).  
     
     
         18 . The method of  claim 1 ,  2 ,  3 ,  4  or  5  wherein said daily dosage is administered for about 1 weeks to about 8 weeks.  
     
     
         19 . The method of  claim 18  wherein said daily dosage is administered for about 5 weeks to about 8 weeks.  
     
     
         20 . The method of  claim 18  wherein said daily dosage is administered for about 6 weeks.