Granted Patent B2

US 12,239,632 · App. 18/595,206 · Granted Mar 4, 2025

Inventors: Paul F. Daley (El Sobrante, CA); Nicholas V. Cozzi (Slinger, WI); Wyeth B. Callaway (Castro Valley, CA)

Assignee: Alexander Shulgin Research Institute, Inc.

A61K31/4045A61K45/06C07D209/16

Abstract

Claims (21)

1. A compound having the structure of

or a pharmaceutically acceptable salt, hydrate, or solvate thereof.

2. A pharmaceutical composition comprising the compound of claim 1 , or a pharmaceutically acceptable salt, hydrate, or solvate thereof, and a pharmaceutically acceptable carrier, diluent, or excipient.

3. The pharmaceutical composition of claim 2 , wherein the composition is suitable for oral, buccal, sublingual, intranasal, injectable, subcutaneous, intravenous, or transdermal administration.

4. The pharmaceutical composition of claim 2 , wherein the composition is in a unit dosage form.

5. The pharmaceutical composition of claim 4 , comprising the compound in a total amount of between 1 mg and 100 mg.

6. The pharmaceutical composition of claim 4 , wherein the unit dosage form is an immediate release formulation, a controlled release formulation, a sustained release formulation, an extended release formulation, or a modified release formulation.

7. The pharmaceutical composition of claim 2 , further comprising a therapeutically effective amount of an additional active compound.

8. The pharmaceutical composition of claim 7 , wherein the additional active compound is an amino acid, an antioxidant, an anti-inflammatory agent, an analgesic, an antineuropathic agent, an antinociceptive agent, an antimigraine agent, an anxiolytic, an antidepressant, an antipsychotic, an anti-PTSD agent, a dissociative, a cannabinoid, an immunostimulant, an anti-cancer agent, an antiemetic, an orexigenic, an antiulcer agent, an antihistamine, an antihypertensive, an anticonvulsant, an antiepileptic, a bronchodilator, a neuroprotectant, a nootropic, an empathogen, a psychedelic, a monoamine oxidase inhibitor, a tryptamine, a terpene, a phenethylamine, a sedative, a stimulant, a serotonergic agent, or a vitamin.

9. A method of treating a mental health disorder in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of the pharmaceutical composition of claim 2 , wherein the mental health disorder is an affective disorder, depression, a depressive disorder, anxiety, an anxiety disorder, post-traumatic stress disorder (PTSD), or obsessive-compulsive disorder (OCD).

10. The method of claim 9 , wherein the depressive disorder is major depressive disorder (MDD), treatment-resistant depression (TRD), atypical depression, postpartum depression, catatonic depression, seasonal affective disorder, or dysthymia (persistent depressive disorder).

11. The method of claim 10 , wherein the depressive disorder is MDD.

12. The method of claim 10 , wherein the depressive disorder is TRD.

13. The method of claim 9 , wherein the anxiety disorder is generalized anxiety disorder (GAD).

14. The method of claim 9 , wherein the mental health disorder is PTSD.

15. The method of claim 9 , wherein the mental health disorder is an affective disorder.

16. The method of claim 9 , wherein the pharmaceutical composition is administered by any of oral, buccal, sublingual, intranasal, injectable, subcutaneous, intravenous, or transdermal administration.

17. The method of claim 9 , wherein the pharmaceutical composition is administered together with one or more sessions of psychotherapy or psychological support.

18. The compound of claim 1 , wherein the pharmaceutically acceptable salt is an acid addition salt.

19. The compound of claim 1 , wherein the pharmaceutically acceptable salt is a hydrochloride, hydrobromide, sulfate, phosphate, acetate, tartrate, or maleate salt.

20. The compound of claim 19 , wherein the pharmaceutically acceptable salt is a hydrochloride salt.

Assignments (4)

Continuity (3)

References Cited (200)