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) (R)-3,4-methylenedioxymethamphetamine ((R)-MDMA) or pharmaceutically acceptable salt thereof in an enantiomeric purity of greater than 98%; and
(ii) a pharmaceutically acceptable carrier.
2 . The oral dosage form of claim 1 , wherein the salt is a hydrochloride salt.
3 . The oral dosage form of claim 1 , wherein the dosage form comprises 75 to 1000 mg of (R)-MDMA.
4 . The oral dosage form of claim 3 , wherein the dosage form comprises 75 to 225 mg of (R)-MDMA.
5 . The oral dosage form of claim 3 , wherein the dosage form comprises 225 to 600 mg of (R)-MDMA.
6 . The oral dosage form of claim 5 , wherein the dosage form comprises 500 to 600 mg of (R)-MDMA.
7 . The oral dosage form of claim 5 , wherein the dosage form comprises 300 to 600 mg of (R)-MDMA.
8 . The oral dosage form of claim 1 , wherein the enantiomeric purity of (R)-MDMA is greater than 99%.
9 . The oral dosage form of claim 8 , wherein the salt is a hydrochloride salt.
10 . The oral dosage form of claim 1 , wherein the dosage form comprises
300 to 600 mg of (R)-MDMA, and
wherein the (R)-MDMA is a hydrochloride salt.
11 . The oral dosage form of claim 10 , wherein the dosage form comprises 500 to 600 mg of (R)-MDMA.
12 . The oral dosage form of claim 11 , wherein the enantiomeric purity of (R)-MDMA is greater than 99%.
13 . The oral dosage form of claim 12 , wherein the enantiomeric purity of (R)-MDMA is 100%.
14 . A method of treating post-traumatic stress disorder in a patient in need thereof, the method comprising orally administering to the patient an oral dosage form, the oral dosage form comprising:
(i) (R)-MDMA or pharmaceutically acceptable salt thereof in an enantiomeric purity of greater than 98%; and
(ii) a pharmaceutically acceptable carrier.
15 . The method of claim 14 , wherein the salt is a hydrochloride salt.
16 . The method of claim 14 , wherein 75 to 1000 mg of (R)-MDMA is administered to the patient.
17 . The method of claim 16 , wherein 75 to 225 mg of (R)-MDMA is administered to the patient.
18 . The method of claim 16 , wherein 225 to 600 mg of (R)-MDMA is administered to the patient.
19 . The method of claim 18 , wherein 500 to 600 mg of (R)-MDMA is administered to the patient.
20 . The method of claim 14 , wherein the 300 to 600 mg of (R)-MDMA is administered to the patient.
21 . The method of claim 14 , wherein the enantiomeric purity of (R)-MDMA is greater than 99%.
22 . The method of claim 21 , wherein the salt is a hydrochloride salt.
23 . A method of treating post-traumatic stress disorder in a patient in need thereof, the method comprising orally administering to the patient 300 to 600 mg of (R)-MDMA in an enantiomeric purity of greater than 98%, wherein the (R)-MDMA is a hydrochloride salt.
24 . The method of claim 23 , wherein 500 to 600 mg of (R)-MDMA is administered.
25 . The method of claim 24 , wherein the enantiomeric purity of (R)-MDMA is greater than 99%.
26 . The method of claim 25 , wherein the enantiomeric purity of (R)-MDMA is 100%.
27 . A method of treating an eating disorder in a patient in need thereof, the method comprising orally administering to the patient an oral dosage form, the oral dosage form comprising:
(i) (R)-MDMA or pharmaceutically acceptable salt thereof in an enantiomeric purity of greater than 98%; and
(ii) a pharmaceutically acceptable carrier.