Claims for Patent: 11,446,258

Summary for Patent: 11,446,258

Title:	Use of cannabinoids in the treatment of epilepsy
Abstract:	The present disclosure relates to the use of cannabidiol (CBD) for the treatment of atonic seizures. In particular the CBD appears particularly effective in reducing atonic seizures in patients suffering with etiologies that include: Lennox-Gastaut Syndrome; Tuberous Sclerosis Complex; Dravet Syndrome; Doose Syndrome; Aicardi syndrome; CDKL5 and Dup15q in comparison to other seizure types. The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).
Inventor(s):	Geoffrey Guy, Stephen Wright, Orrin Devinsky
Assignee:	Jazz Pharmaceuticals Research Uk Ltd
Application Number:	US17/477,172
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,446,258
Patent Claims:	1. A method of treating seizures in a patient having Lennox-Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex, or Doose Syndrome comprising orally administering to the patient a pharmaceutical formulation comprising cannabidiol (CBD), wherein the CBD is present in the pharmaceutical formulation at a concentration of about 100 mg/mL, and wherein the patient is administered a starting dose of CBD of about 5 mg/kg/day, and after administering the starting dose, the starting dose of CBD is gradually increased by about 5 mg/kg increments up to a maximum of about 25 mg/kg/day. 2. The method of claim 1, wherein the starting dose of CBD is increased to a dose ranging from about 10 mg/kg/day to about 25 mg/kg/day. 3. The method of claim 1, wherein the starting dose of CBD is increased to about 10 mg/kg/day. 4. The method of claim 1, wherein the starting dose of CBD is increased to about 15 mg/kg/day. 5. The method of claim 1, wherein the starting dose of CBD is increased to about 20 mg/kg/day. 6. The method of claim 1, wherein the starting dose of CBD is increased to about 25 mg/kg/day. 7. The method of claim 1, wherein the seizures are atonic seizures, tonic seizures, clonic seizures, tonic-clonic seizures, absence seizures, or myoclonic seizures. 8. The method of claim 2, wherein the seizures are atonic seizures, tonic seizures, clonic seizures, tonic-clonic seizures, absence seizures, or myoclonic seizures. 9. The method of claim 3, wherein the seizures are atonic seizures, tonic seizures, clonic seizures, tonic-clonic seizures, absence seizures, or myoclonic seizures. 10. The method of claim 4, wherein the seizures are atonic seizures, tonic seizures, clonic seizures, tonic-clonic seizures, absence seizures, or myoclonic seizures. 11. The method of claim 5, wherein the seizures are atonic seizures, tonic seizures, clonic seizures, tonic-clonic seizures, absence seizures, or myoclonic seizures. 12. The method of claim 6, wherein the seizures are atonic seizures, tonic seizures, clonic seizures, tonic-clonic seizures, absence seizures, or myoclonic seizures. 13. The method of claim 1, comprising treating seizures in a patient having Lennox-Gastaut syndrome. 14. The method of claim 13, wherein the starting dose of CBD is increased to a dose ranging from about 10 mg/kg/day to about 20 mg/kg/day. 15. The method of claim 13, wherein the starting dose of CBD is increased to about 10 mg/kg/day. 16. The method of claim 13, wherein the starting dose of CBD is increased to about 20 mg/kg/day. 17. The method of claim 1, comprising treating seizures in a patient having Dravet syndrome. 18. The method of claim 17, wherein the starting dose of CBD is increased to a dose ranging from about 10 mg/kg/day to about 20 mg/kg/day. 19. The method of claim 17, wherein the starting dose of CBD is increased to about 10 mg/kg/day. 20. The method of claim 17, wherein the starting dose of CBD is increased to about 20 mg/kg/day. 21. The method of claim 1, comprising treating seizures in a patient having Tuberous Sclerosis Complex. 22. The method of claim 21, wherein the starting dose of CBD is increased to a dose ranging from about 10 mg/kg/day to about 25 mg/kg/day. 23. The method of claim 21, wherein the starting dose of CBD is increased to about 25 mg/kg/day. 24. The method of claim 1, comprising treating seizures in a patient having Doose Syndrome. 25. The method of claim 24, wherein the starting dose of CBD is increased to a dose ranging from about 10 mg/kg/day to about 25 mg/kg/day. 26. The method of claim 24, wherein the starting dose of CBD is increased to about 10 mg/kg/day. 27. The method of claim 24, wherein the starting dose of CBD is increased to about 20 mg/kg/day. 28. The method of claim 24, wherein the starting dose of CBD is increased to about 25 mg/kg/day. 29. The method of claim 1, wherein the administering reduces the number of seizures by at least 50% compared to the number of seizures experienced during a baseline period before CBD was administered.