Granted Patent B2

US 12,239,628 · App. 18/460,012 · Granted Mar 4, 2025

Inventors: Harry Karelis (Perth, AU); Mara Gordon (Bodega Bay, CA); Stewart Smith (Bodega Bay, CA); Stewart Washer (Stirling, AU)

Assignee: Zelira Therapeutics Operations Pty Ltd

A61K31/352A61K31/05A61K47/06A61P25/20A61K36/185

Abstract

Claims (37)

1. A method for treating a sleep disorder, comprising administering to a patient in need thereof an effective amount of a pharmaceutical composition, wherein the pharmaceutical composition comprises a Cannabis extract and optionally one or more pharmaceutically acceptable carriers, diluents, adjuvants, excipients or any combination thereof, the Cannabis extract comprising:

Δ 9 -Tetrahydrocannabinol (THC) in an amount of from 50% to 90% by weight of the Cannabis extract;

Cannabidiol (CBD) in an amount of up to 10% by weight of the Cannabis extract;

Cannabinol (CBN) in an amount of up to 10% by weight of the Cannabis extract; and

a terpene fraction in an amount of more than 1% by weight of the Cannabis extract, the terpene fraction comprising:

a nerolidol being absent or in an amount of from about 0.01% to about 20% by weight of the terpene fraction;

beta-myrcene in an amount of up to 40% by weight of the terpene fraction;

linalool in an amount of at least 5% by weight of the terpene fraction;

alpha-pinene in an amount of from 0.001% to 20% by weight of the terpene fraction; and

beta-pinene in an amount of from 0.001% to 80% by weight of the terpene fraction.

2. The method according to claim 1 , wherein the Cannabis extract comprises THC in an amount from 55 to 85% by weight of the extract.

3. The method according to claim 1 , wherein the Cannabis extract comprises Δ 9 -Tetrahydrocannabivarin (THCV) in an amount from 0.001% to 10% by weight of the Cannabis extract.

4. The method according to claim 1 , wherein the terpene fraction comprises beta-pinene in an amount of at least 5% by weight of the terpene fraction.

5. The method according to claim 1 , wherein the terpene fraction comprises alpha-pinene in an amount of from about 0.001% to 20% by weight of the terpene fraction.

6. The method according to claim 5 , wherein the terpene fraction comprises alpha-pinene in an amount of at least 5% by weight of the terpene fraction.

7. The method according to claim 1 , wherein the terpene fraction comprises a nerolidol in an amount of from about 0.01% to about 20% by weight of the terpene fraction.

8. The method according to claim 1 , wherein the terpene fraction is present in an amount of up to 10% by weight of the Cannabis extract.

9. The method according to claim 1 , wherein

the Cannabis extract comprises:

THC in an amount from 55 to 85% by weight of the Cannabis extract;

CBD in an amount from 0.001% to 10% by weight of the Cannabis extract;

CBN in an amount from 0.001% to 10% by weight of the Cannabis extract;

THCV in an amount from 0.001% to 10% by weight of the Cannabis extract;

the terpene fraction is present in an amount of up to 10% by weight of the Cannabis extract, and the terpene fraction comprises:

beta-pinene in an amount of at least 5% by weight of the terpene fraction;

alpha-pinene in an amount of from about 0.001% to 20% by weight of the terpene fraction;

beta-myrcene in an amount of up to about 40% by weight of the terpene fraction; and

a nerolidol in an amount of from about 0.01% to about 20% by weight of the terpene fraction.

10. The method according to claim 1 , wherein the pharmaceutical composition comprises an oil.

11. The method according to claim 1 , wherein the composition is administered by a route selected from the group consisting of oral, buccal and sub-lingual.

12. The method according to claim 11 , wherein the composition is administered sublingually.

13. The method according to claim 1 , wherein the sleep disorder is selected from the group consisting of insomnia, narcolepsy, hypersomnia, sleep apnea, periodic limb movement disorder, restless legs syndrome, nocturnal eating (drinking) syndrome, jet lag, shift work sleep disorder, irregular sleep-wake pattern, confusional arousals, sleepwalking, sleep terrors, sleep talking, nightmares, sleep paralysis, REM sleep behaviour disorder, snoring, or sleeping sickness.

14. The method according to claim 13 , wherein the sleep disorder is insomnia.

15. The method according to claim 1 , wherein the method achieves one or more of the following:

(a) assisting the patient to fall asleep;

(b) assisting the patient remain asleep once sleep has been achieved; or

(c) relieving or ameliorating the effects of the sleep disorder, including enhancing wakefulness during non-sleep periods.

Continuity (4)

References Cited (67)