METHODS FOR TREATING SUBJECTS WITH PRADER-WILLI SYNDROME OR SMITH-MAGENIS SYNDROME
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.