Methods for treating subjects with prader-willi syndrome or smith-magenis syndrome

Abstract

Provided are immediate or prolonged administration of certain potassium ATP (KATP) channel openers, optionally in combination with growth hormone, to a subject to achieve novel pharmacodynamic, pharmacokinetic, therapeutic, physiological, metabolic and compositional outcomes in the treatment of diseases or conditions involving KATP channels. Also provided are pharmaceutical formulations, methods of administration and dosing of KATP channel openers that achieve these outcomes and reduce the incidence of adverse effects in treated individuals. Further provided are methods of co-administering KATP channel openers with other drugs (e.g., in combination with growth hormone) to treat diseases of humans and animals (e.g., Prader-Willi Syndrome (PWS), Smith-Magenis syndrome (SMS), and the like.

1 .- 28 . (canceled) 
     
     
         29 . A kit comprising a pharmaceutical formulation, wherein the pharmaceutical formulation comprises a K ATP  channel opener,
 wherein the kit is for treatment of hyperghrelinemia in a subject having Prader-Willi syndrome (PWS) or Smith-Magenis syndrome (SMS).   
     
     
         30 . The kit of  claim 29 , wherein the K ATP  channel opener is diazoxide, or a pharmaceutically acceptable salt thereof. 
     
     
         31 . The kit of  claim 30 , wherein the pharmaceutically acceptable salt is diazoxide choline. 
     
     
         32 . The kit of  claim 29 , wherein the pharmaceutical formulation is administered once per day. 
     
     
         33 . The kit of  claim 29 , wherein the pharmaceutical formulation is administered twice per day. 
     
     
         34 . The kit of  claim 29 , wherein the pharmaceutical formulation comprises at least one excipient that affects the rate of release of the K ATP  channel opener or the pharmaceutically acceptable salt thereof. 
     
     
         35 . The kit of  claim 29 , wherein the pharmaceutical formulation comprises at least one excipient that delays release of the K ATP  channel opener or the pharmaceutically acceptable salt thereof. 
     
     
         36 . The kit of  claim 29 , wherein the pharmaceutical formulation comprises at least one other active ingredient. 
     
     
         37 . The kit of  claim 29 , wherein the pharmaceutical formulation is administered for 1 or more years. 
     
     
         38 . The kit of  claim 29 , wherein the pharmaceutical formulation is administered orally. 
     
     
         39 . The kit of  claim 29 , wherein the subject is an adult. 
     
     
         40 . The kit of  claim 29 , wherein the subject is over the age of 16. 
     
     
         41 . The kit of  claim 29 , wherein the kit further comprises one or more of a label, instructions, or reagents.