ENANTIOMERIC RATIOS OF 3,4-METHYLENEDIOXYMETHAMPHETAMINE AND RELATED METABOLITES AND USES THEREOF
The present disclosure provides compositions comprising (R)-MDMA or a pharmaceutically acceptable salt thereof with no or substantially no (S)-MDMA, pharmaceutically acceptable salt thereof, or metabolite thereof. Also provided herein are methods of using the compositions for treating diseases/disorders, e.g., PTSD.
1 . An oral dosage form comprising:
(i) an (R)-MDMA enantiomer comprising greater than 90% of (R)-MDMA or pharmaceutically acceptable salt thereof; and
(ii) a pharmaceutically acceptable carrier.
2 . The oral dosage form of claim 1 , wherein the pharmaceutically acceptable salt is a hydrochloride (HCl) salt.
3 . The oral dosage form of claim 1 , wherein the dosage form comprises 75 mg to 1000 mg of (R)-MDMA, based on (R)-MDMA free base.
4 . The oral dosage form of claim 3 , wherein the dosage form comprises 75 mg to 225 mg of (R)-MDMA.
5 . The oral dosage form of claim 3 , wherein the dosage form comprises 225 mg to 600 mg of (R)-MDMA.
6 . The oral dosage form of claim 5 , wherein the dosage form comprises 500 mg to 600 mg of (R)-MDMA.
7 . The oral dosage form of claim 1 , wherein the dosage form comprises greater than 95% of (R)-MDMA.
8 . The oral dosage form of claim 1 , wherein the dosage form comprises 97% of (R)-MDMA.
9 . The oral dosage form of claim 1 , wherein the oral dosage form comprises:
(i) 225 mg to 1000 mg, based on (R)-MDMA free base, of a hydrochloride (HCl) salt of (R)-MDMA enantiomer comprising greater than 90% (R)-MDMA; and
(ii) a pharmaceutically acceptable carrier.
10 . The oral dosage form of claim 9 , wherein the dosage form comprises 500 mg to 600 mg of the HCl salt of (R)-MDMA, based on (R)-MDMA free base.
11 . The oral dosage form of claim 9 , wherein the dosage form comprises greater than 95% of (R)-MDMA.
12 . The oral dosage form of claim 9 , wherein the dosage form comprises 97% of (R)-MDMA.
13 . A method of treating post-traumatic stress disorder (PTSD), comprising administering to a patient in need thereof an oral dosage form comprising:
(i) an (R)-MDMA enantiomer comprising greater than 90% of (R)-MDMA or pharmaceutically acceptable salt thereof; and
(ii) a pharmaceutically acceptable carrier.
14 . The method of claim 13 , wherein the pharmaceutically acceptable salt is a hydrochloride (HCl) salt.
15 . The method of claim 13 , wherein the oral dosage form comprises 75 mg to 100 mg of (R)-MDMA, based on (R)-MDMA free base.
16 . The method of claim 15 , wherein the oral dosage form comprises 75 mg to 225 mg of (R)-MDMA.
17 . The method of claim 15 , wherein the oral dosage form comprises 225 mg to 600 mg of (R)-MDMA.
18 . The method of claim 15 , wherein the oral dosage form comprises 500 mg to 600 mg of (R)-MDMA.
19 . The method of claim 13 , wherein the oral dosage form comprises greater than 95% of (R)-MDMA.
20 . The method of claim 13 , wherein the oral dosage form comprises 97% of (R)-MDMA.
21 . A method of treating post-traumatic stress disorder (PTSD), comprising administering to a patient in need thereof an oral dosage form comprising:
(i) 225 mg to 1000 mg, based on (R)-MDMA free base, of a hydrochloride (HCl) salt of an (R)-MDMA enantiomer comprising greater than 90% of (R)-MDMA or pharmaceutically acceptable salt thereof; and
(ii) a pharmaceutically acceptable carrier.
22 . The method of claim 21 , wherein the oral dosage form comprises 500 mg to 600 mg of the HCl salt of (R)-MDMA, based on (R)-MDMA free base.
23 . The method of claim 21 , wherein the oral dosage form comprises greater than 95% of the HCl salt of (R)-MDMA.
24 . The method of claim 21 , wherein the oral dosage form comprises 97% of the HCl salt of (R)-MDMA.
25 . A method of treating an eating disorder, comprising administering to a patient in need thereof an oral dosage form comprising:
(i) an (R)-MDMA enantiomer comprising greater than 90% of (R)-MDMA or pharmaceutically acceptable salt thereof; and
(ii) a pharmaceutically acceptable carrier.