PSILOCIN BENZOATE FORMULATION FOR INTRAVENOUS INFUSION

1 . A pharmaceutical composition comprising (i) an aqueous solution having a pH of between about 3.5 and about 6.5, (ii) between about 0.0053 mg/mL and about 4.0 mg/ml of psilocin benzoate, and (iii) an antioxidant, wherein the pharmaceutical composition is suitable for infusion.

2 . The pharmaceutical composition of claim 1 , wherein the aqueous solution comprises a citrate buffer, an acetate buffer, or a phosphate buffer, and has a pH of between about 4.0 and about 6.0.

3 . A pharmaceutical composition comprising (i) a citrate buffered aqueous solution having a pH of between about 4.0 and about 5.0, and (ii) between about 0.0053 mg/mL and about 4.0 mg/ml of psilocin benzoate, wherein the pharmaceutical composition is suitable for infusion.

4 . The pharmaceutical composition of any one of claims 1-3 , wherein the aqueous solution comprises between about 0.001% (w/v) to 2% (w/v) of an antioxidant.

5 . The pharmaceutical composition of any one of claims 1-4 , wherein the antioxidant is vitamin C, thioglycerol, sodium bisulfite, or sodium sulfite.

6 . The pharmaceutical composition of claim 5 , wherein the aqueous solution comprises about 0.01+0.005% sodium bisulfite.

7 . The pharmaceutical composition of any one of claims 1-6 , wherein the pharmaceutical composition further comprises one or more pharmaceutically acceptable excipients selected from a preservative, or a tonicity agent.

8 . The pharmaceutical composition of claim 7 , wherein the pharmaceutical composition further comprises from 0.1% (w/v) to 1% (w/v) sodium chloride as a tonicity agent.

9 . The pharmaceutical composition of any one of claims 1-8 , wherein the pharmaceutical composition comprises: (i) a citrate buffered aqueous solution having a pH of between 4.0 and 5.0, (ii) between about 0.0053 mg/mL and about 0.7 mg/mL of psilocin benzoate, and (iii) 0.01 to 0.075% (w/v) sodium bisulfite.

10 . The pharmaceutical composition of claim 9 , wherein the pharmaceutical comprises from about 50 to about 200 mM citrate buffer.

11 . A reconstitutable powder comprising psilocin benzoate, an antioxidant, and a buffer, wherein reconstitution of the reconstitutable powder in from 5 mL to 50 ml of an aqueous solution produces the pharmaceutical composition of any one of claims 1-10 .

12 . The reconstitutable powder of claim 11 , wherein the powder comprises between about 0.01% (w/w) and 2% (w/w) of psilocin benzoate.

13 . A method of treating a disease or condition in a subject in need thereof, the method comprising intravenously administering to the subject a pharmaceutical composition of any one of claims 1-10 in an amount sufficient to treat the disease or condition.

14 . A method of treating a disease or condition in a subject in need thereof, the method comprising intravenously administering to the subject a pharmaceutical composition of any one of claims 1-10 over a period of between 1 minute and 60 minutes.

15 . The method of claim 13 or claim 14 , wherein the pharmaceutical composition is administered to the subject over a period of 20 to 60 minutes.

16 . The method of any one of claims 13-15 , wherein the disease or condition is a neurological injury, a neurodegenerative disease, an inflammatory condition, chronic pain, or a psychological condition.

17 . The method of claim 16 , wherein the disease or condition is an inflammatory condition.

18 . The method of claim 17 , wherein the inflammatory condition is lung inflammation, neuroinflammation, rheumatoid arthritis, atherosclerosis, psoriasis, type II diabetes, inflammatory bowel disease, Crohn's disease, multiple sclerosis, and/or septicemia.

19 . The method of claim 17 , wherein the inflammatory condition is chronic obstructive pulmonary disease (COPD), or Alzheimer's disease.

20 . The method of claim 16 , wherein the disease or condition is a neurological injury.

21 . The method of claim 20 , wherein the neurological injury is a stroke, a traumatic brain injury, or a spinal cord injury.

22 . The method of claim 16 , wherein the disease or condition is chronic pain.

23 . The method of claim 22 , wherein the chronic pain results from post-operative pain, tension headaches, chronic lower back pain, fibromyalgia, nephropathy, multiple sclerosis, shingles, complex regional pain syndrome, cephalic pain, or sciatica.

24 . The method of claim 22 , wherein the chronic pain condition results from trigeminal autonomic cephalalgia.

25 . The method of claim 24 , wherein the trigeminal autonomic cephalalgia is selected from the group consisting of episodic and chronic cluster headache (CH), episodic and chronic paroxysmal hemicrania (PH), and short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT).

26 . The method of claim 25 , wherein the trigeminal autonomic cephalalgia is episodic or chronic CH.

27 . The method of claim 16 , wherein the condition is a psychological condition.

28 . The method of claim 27 , wherein the psychological condition is depression, anxiety, addiction, post-traumatic stress disorder, an eating disorder, or compulsive behavior.

29 . The method of claim 27 , wherein the psychological condition is depression.

30 . The method of claim 27 , wherein the psychological condition is anxiety.

31 . The method of claim 16 , wherein the disease or condition is a neurodegenerative disease selected from Alzheimer's disease, Huntington's disease, and Parkinson's disease.

32 . The method of any one of claims 13-31 , wherein the method comprises further administering to the patient a pharmacologically effective amount of an antiemetic agent.

33 . The method of claim 32 , wherein the antiemetic agent comprises a non-selective 5-HT antagonist, 5-HT3 receptor antagonist, 5-HT4 receptor agonist, CB1 agonist, D2 receptor antagonist, D3 receptor antagonist, GABA receptor agonist, H1 receptor antagonist, muscarinic acetylcholine receptor antagonist, NK1 receptor antagonist, or a combination thereof.

34 . The method of claim 32 or claim 33 , wherein the antiemetic ondansetron is intravenously infused.

35 . The method of any one of claims 13-34 , wherein the intravenous infusion comprises a pharmacologically effective amount of a benzodiazepine.

36 . The method of claim 35 , wherein the benzodiazepine is a 1,4-benzodiazepine, 1,5-benzodiazepine, 2,3-benzodiazepine, triazolobenzodiazepine, imidazobenzodiazepine, oxazolobenzodiazepine, thienodiazepine, thienotriazolodiazepine, thienobenzodiazepine,pyridodiazepine, pyridotriazolodiazepine, pyrralodiazepine, tetrahydroisoquinobenzodiazepine, a benzodiazepine prodrug, or a combination thereof.

37 . The method of claims 35 and 36 , wherein the benzodiazepine is lorazepam or diazepam.

38 . The method of any one of claims 35-37 , wherein the benzodiazepine is administered in a dosage between 2 mg and 10 mg.

39 . The method of any one of claims 13-38 , wherein the intravenous infusion comprises a pharmacologically effective amount of an anesthetic, a sedative, an antiemetic, an anticonvulsant, an antidepressant, an antimigraine, an antipsychotic, an anxiolytic, and/or an antiparkinson agent.

40 . The method of any one of claims 13-39 , further comprising administering to the patient a preparation comprising a pharmacologically effective amount of an anti-inflammatory agent.

41 . The method of claim 40 , wherein the administration of the preparation is an intravenous infusion of ketorolac or pharmaceutically acceptable salt thereof.

42 . The method of claim 40 , wherein the administration of the preparation is an intramuscular infusion of a pharmacologically effective amount of a triptan or a pharmaceutically acceptable salt thereof.

43 . The method of claim 40 , wherein the preparation comprises sumatriptan or a pharmaceutically acceptable salt thereof.

44 . The method of any one of claims 13-43 , wherein the intravenous infusion comprising a pharmacologically effective amount of psilocin benzoate is administered at least twice over the course of a month.

45 . The method of claim 44 , wherein the intravenous infusion comprising a pharmacologically effective amount of psilocin benzoate is administered between 2 and 10 times over the course of a year.