Claims for Patent: 9,757,384

Summary for Patent: 9,757,384

Title:	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.
Inventor(s):	Neil M. Cowen
Assignee:	Essentialis Inc
Application Number:	US14/940,018
Patent Claims:	1. A method of reducing one or more aggressive behaviors in a subject having Prader-Willi syndrome (PWS) or Smith-Magenis syndrome (SMS), the method comprising administering to said subject for at least 10 weeks a pharmaceutical formulation comprising an effective amount of diazoxide or a pharmaceutically acceptable salt thereof, wherein administration reduces one or more aggressive behaviors in the subject. 2. The method of claim 1 wherein the pharmaceutically acceptable salt is diazoxide choline. 3. The method of claim 1 wherein said pharmaceutical formulation is administered orally. 4. The method of claim 1 wherein the pharmaceutical formulation includes at least one excipient which affects the rate of release of diazoxide or a pharmaceutically acceptable salt thereof. 5. The method of claim 4 wherein the pharmaceutical formulation includes at least one excipient that delays release of diazoxide or a pharmaceutically acceptable salt thereof. 6. The method of claim 1 wherein the pharmaceutical formulation further comprises at least one other active ingredient. 7. The method of claim 1 further comprising administering human growth hormone to the subject. 8. The method of claim 7 wherein said human growth hormone is administered by injection. 9. The method of claim 1 wherein said administering is carried out for one or more years. 10. The method of claim 1, wherein the circulating concentration of IGF-1 is not increased. 11. The method of claim 1 in which a second therapeutic product is administered, wherein the second product is intended to further reduce the one or more aggressive behaviors. 12. The method of claim 1 wherein the pharmaceutical formulation is administered twice per day. 13. The method of claim 1 wherein the pharmaceutical formulation is administered once per day. 14. A method of reducing one or more aggressive behaviors in a subject having Prader-Willi syndrome (PWS) or Smith-Magenis syndrome (SMS), the method comprising administering to said subject for at least 10 weeks an effective amount of a formulation consisting essentially of diazoxide or a pharmaceutically acceptable salt thereof, wherein administration reduces one or more aggressive behaviors in the subject.