Claims for Patent: 10,881,663
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Summary for Patent: 10,881,663
| Title: | Method of treating pain in elderly patients with mild renal impairment |
| Abstract: | The present disclosure relates to administration of meloxicam intravenously, for treatment of pain, in patients who are at least 65 years old and have mild renal impairment, which can provide fast onset of pain relief suitable for management of acute pain as well as moderate to severe pain. |
| Inventor(s): | Mack; Randall J. (Malvern, PA), McCallum; Stewart (Malvern, PA), Gomez; Alexis (Malvern, PA), Freyer; Alex (Malvern, PA) |
| Assignee: | BAUDAX BIO, INC. (Malvern, PA) |
| Application Number: | 16/297,020 |
| Patent Claims: |
1. A method of treating pain, comprising administering to a patient in need thereof meloxicam intravenously at a dose of about 30 mg, wherein the patient is at least
65 years old and has mild renal impairment; wherein administration of meloxicam at the dose of about 30 mg is safe and well tolerated with no clinically meaningful differences between the patient and subjects aged 18 to 55 years with normal renal
function (GFR>90 mL/min/1.73 m.sup.2), and the meloxicam is present as meloxicam nanocrystals.
2. The method of claim 1, wherein the dose of meloxicam is administered to the patient in a bolus dose. 3. The method of claim 1, wherein the dose of meloxicam is administered to the patient over the course of about 1 to about 60 seconds. 4. The method of claim 3, wherein the dose of meloxicam is administered to the patient over the course of about 15 to about 30 seconds. 5. The method of claim 1, wherein the meloxicam is present in a volume of from about 0.5 mL to about 4 mL. 6. The method of claim 5, wherein the meloxicam is present in a volume of about 1 mL. 7. The methods of claim 1, wherein the pain is post-surgical pain. 8. The method of claim 1, wherein the dose of meloxicam is administered after the patient has undergone a surgical procedure. 9. The method of claim 8, wherein the surgical procedure is an open surgical procedure. 10. The method of claim 8, wherein the surgical procedure is a laparoscopic surgical procedure. 11. The method of claim 8, wherein the surgical procedure was performed on hard tissue. 12. The method of claim 8, wherein the surgical procedure was performed on soft tissue. 13. The method of claim 1, wherein the pain is moderate to severe pain. 14. The method of claim 1, wherein the pain is mild to moderate pain. 15. The method of claim 1, further comprising administering meloxicam to the patient about every 16 hours to about every 26 hours after administering to the patient meloxicam intravenously at a dose of about 30 mg, and until the patient is no longer in need thereof. 16. The method of claim 1, wherein meloxicam is administered to the patient about 18 hours to about every 24 hours after administering to the patient meloxicam intravenously at a dose of about 30 mg, and until the patient is no longer in need thereof. |
