Methods for preventing and treating post-traumatic stress disorder (PTSD)

• US 9,707,274 B2
• Filed: 09/30/2013
• Issued: 07/18/2017
• Est. Priority Date: 06/08/2007
• Status: Active Grant

• Current Assignee: HealthPartners Research and Educatio
• Original Assignee: HealthPartners Research and Educatio
• Inventors: Frey, II, William H.
• Primary Examiner(s): Weidner, Adam M
• Application Number:
  US14/040,915
• Publication Number:
  US 20140031280A1
• Time in Patent Office: 1,387 Days
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/4164 1,3-Diazoles
• CPC Class Codes: A61K 33/24 Heavy metals; Compounds thereof
• CPC Class Codes: A61K 38/191 Tumor necrosis factors [TNF], e.g. lymphotoxin [LT], i.e. TNF-beta
• CPC Class Codes: A61K 38/2006 IL-1
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system

Abstract

Methods for preventing and/or treating symptoms of Post-Traumatic Stress Disorder (PTSD) are provided. The preferred method comprises administration of an effective amount of insulin to the upper one-third of a mammal'"'"'s, preferably a human, nasal cavity, thereby enabling the administered at least one effective amount of insulin to bypass the patient'"'"'s blood-brain barrier and be directly delivered to the patient'"'"'s CNS. Another embodiment comprises utilizing vasoconstrictors to enhance targeting of an effective amount of insulin to the CNS while reducing non-target exposure.

Claims

1. A method for treating a patient for Post-Traumatic Stress Disorder (PTSD) resulting from witnessing an event, the witnessed event consisting of an occupational situation involving violence, serious injury, and/or death, comprising:

identifying the patient witnessing the event;

providing at least one effective amount of a therapeutic compound comprising an insulin;

during the patient'"'"'s witnessing of the event, administering the at least one effective amount of the therapeutic compound comprising an insulin to the upper one-third of the nasal cavity of the patient, thereby enabling the administered at least one effective amount of the therapeutic compound comprising an insulin to bypass the patient'"'"'s blood-brain barrier; and

thereby enabling delivery of the at least one effective amount of the therapeutic compound comprising an insulin to the patient'"'"'s central nervous system (CNS) to treat the patient for PTSD during the patient'"'"'s witnessing of the event.

2. A method for treating a patient for PTSD resulting from the witnessing of an event consisting of an occupational situation involving violence, serious injury, and/or death comprising:

identifying the event and the patient who will witness the event;

providing at least one effective amount of a therapeutic compound comprising an insulin;

before the patient witnesses the event, administering the at least one effective amount of the therapeutic compound comprising an insulin to the upper one-third of the nasal cavity of the patient, thereby enabling the administered at least one effective amount of the therapeutic compound comprising an insulin to bypass the patient'"'"'s blood-brain barrier; and

thereby enabling delivery of the at least one effective amount of the therapeutic compound comprising an insulin to the patient'"'"'s central nervous system (CNS) to treat the patient for PTSD before the patient witnesses the event.

3. The method of claim 2, wherein the therapeutic compound comprising insulin does not contain zinc.

4. The method of claim 3, wherein the insulin is glulisine.

5. The method of claim 2, further comprising administering a vasoconstrictor to the patient.

6. The method of claim 5, wherein the at least one vasoconstrictor comprises tetrahydrozoline.

7. The method of claim 5, wherein the at least one vasoconstrictor comprises phenylephrine.

8. The method of claim 5, wherein the vasoconstrictor is administered intranasally to the patient.

9. The method of claim 5, wherein an effective amount of the vasoconstrictor dosage is within the range of 0.0001-0.3 mg/kg.

10. The method of claim 2, wherein the therapeutic compound comprising an insulin further comprises pyrophosphate for preservation and is prepared for unit dosing to administer the at least one effective amount.

11. The method of claim 2, wherein the therapeutic compound comprising an insulin does not contain a cresol or a phenol preservative and is prepared for unit dosing to administer the at least one effective amount.

12. The method of claim 2, wherein an effective amount of the insulin is within the range:

0.0001-1.0 mg/kg.

13. The method of claim 12, wherein a dosage range for the therapeutic compound comprising an insulin is within the range of 0.002-0.1 mg/kg.

14. The method of claim 12, wherein a dosage range for the therapeutic compound comprising an insulin is within the range of 0.03-0.6 mls.

15. The method of claim 2, wherein an effective amount of the insulin is within the range 0.002-1.0 mg/kg.

16. The method of claim 2, wherein an effective amount of the insulin is within the range 0.002-0.2 mg/kg.

17. The method of claim 2, wherein administration of the at least one effective amount of the therapeutic compound comprising insulin results in a brain concentration of insulin in the range of 0.1 nM-50 μ

M.

18. The method of claim 2, further comprising administering at least one additional effective amount of the therapeutic compound comprising an insulin to the upper one-third of the nasal cavity of the patient during the witnessing of the event.

19. The method of claim 2, further comprising administering at least one additional effective amount of the therapeutic compound comprising an insulin to the upper one-third of the nasal cavity of the patient for a period of time following the witnessing of the event.