Method for treating osteoarthritis pain by administering resiniferatoxin
Disclosed herein are methods of administering resiniferatoxin (RTX) for treatment of osteoarthritis (OA) pain, and compositions for use in such methods.
1. A method for treating osteoarthritis (OA) pain comprising administering a therapeutically effective amount of resiniferatoxin (RTX) to a human subject in need thereof, wherein the administering is by an intra-articular injection to an affected joint; and wherein the composition is a pharmaceutical formulation comprising RTX and a pharmaceutically acceptable carrier at a concentration of 1 μg/mL to 50 μg/mL.
2. The method of claim 1 , wherein the dose of RTX is from about 1 μg to about 100 μg.
3. The method of claim 2 , wherein the dose of RTX is from about 5 μg to about 40 μg.
4. The method of claim 2 , wherein the dose of RTX is about 12.5 μg.
5. The method of claim 2 , wherein the dose of RTX is about 20 μg.
6. The method of claim 1 , wherein the dose of RTX is about 5 μg, 12.5 μg, 20 μg or 30 μg, optionally wherein the dose is in a volume of about 2.5 ml to about 15 ml.
7. The method of claim 1 , wherein the affected joint is a knee joint, a hip joint, a hand joint, a shoulder joint, an ankle joint, a foot joint, an elbow joint, a wrist joint, a sacroiliac joint, or a spine joint, or combinations thereof.
8. The method of claim 1 , wherein the affected joint is a large joint.
9. The method of claim 1 , wherein the RTX is administered to a single site.
10. The method of claim 1 , wherein the RTX is administered to a plurality of sites.
11. The method of claim 1 , wherein the pharmaceutically acceptable carrier comprises polysorbate 80, or wherein the pharmaceutically acceptable carrier comprises polyethylene glycol, or wherein the pharmaceutically acceptable carrier comprises a sugar or sugar alcohol or wherein the pharmaceutically acceptable carrier comprises a pharmaceutically acceptable buffer.
12. The method of claim 1 , wherein the pharmaceutical formulation has a pH in the range of 6 to 7.6.
13. The method of claim 1 , wherein the pharmaceutically acceptable carrier comprises a pharmaceutically acceptable salt.
14. The method of claim 1 , wherein RTX is administered at least one time per year.
15. The method of claim 14 , wherein the administration occurs within a time period of from about 1 week to about 12 months or more.
16. The method of claim 1 , wherein the dose of RTX ranges from 0.1-1 μg, 1-2 μg, 2-5 μg, 5-10 μg, 10-20 μg, 20-30 μg, 30-40 μg, 40-50 μg, 50-60 μg, 60-70 μg, 70-80 μg, 80-90 μg, or 90-100 μg.
17. The method of claim 2 , wherein the dose of RTX is from about 10 μg to about 30 μg.
18. The method of claim 2 , wherein the dose of RTX is from about 15 μg to about 25 μg.