Granted Patent B2

US 12,527,770 · App. 15/799,602 · Granted Jan 20, 2026

Inventors: Jutaro Shudo (San Jose, CA); Wan-Ning Song (San Jose, CA); Rose Marie Gonsalves (Santa Clara, CA); Stephen Shipping Hwang (Palo Alto, CA)

Assignee: Teikoku Pharma USA, Inc.

A61K31/4174A61K9/7038A61K9/7053A61K9/7061A61P29/00A61K45/06

Abstract

Claims (26)

1 . A method of managing post-operative pain in a non-sedated subject, the method comprising:

applying a transdermal delivery device to a skin surface of a non-sedated subject 2 to 14 hours before undergoing surgery, the transdermal delivery device maintaining contact with the skin surface for 72 hours or more after application to the skin surface, the transdermal delivery device comprising:

a dexmedetomidine composition comprising dexmedetomidine and a pressure sensitive adhesive; and

a backing layer,

wherein:

the transdermal delivery device delivers a non-sedative amount of dexmedetomidine of from 50 μg/day to 350 μg/day to the subject;

the transdermal delivery device provides to the subject an average maximal plasma concentration of dexmedetomidine over 72 hours of from 50 μg/mL to 250 μg/mL; and

the method reduces, without sedation (Wilson Sedation Score of 1), the post-operative pain experienced by the subject by a constant amount over at least 72 hours after the surgery and for about 10 hours after the transdermal delivery device has been removed from the skin surface when the transdermal delivery device has been removed 72 hours after application to the skin surface.

2 . The method according to claim 1 , wherein the post-operative pain results from a bony model surgical procedure or a soft tissue model surgical procedure.

3 . The method according to claim 2 , wherein the post-operative pain results from an osteotomy.

4 . The method according to claim 3 , wherein the osteotomy is a bunionectomy.

5 . The method according to claim 1 , wherein the pressure sensitive adhesive is an acrylate pressure sensitive adhesive with pendant hydroxyl functional groups.

6 . The method according to claim 5 , wherein the dexmedetomidine composition further comprises a permeation enhancer.

7 . The method according to claim 6 , wherein the permeation enhancer is lauryl lactate.

8 . The method according to claim 1 , wherein the method further comprises administering an amount of a hydration fluid to the subject.

9 . The method according to claim 1 , wherein the transdermal delivery device has a surface area from 1 cm 2 to 10 cm 2 .

10 . The method of claim 1 , wherein one transdermal delivery device is applied to the subject.

11 . The method of claim 1 , wherein two or more transdermal delivery devices are applied to the subject at the same time.

12 . The method of claim 1 , wherein two transdermal delivery devices are applied to the subject at the same time.

13 . The method of claim 12 , wherein each the transdermal delivery device has a surface area of 6 cm 2 .

14 . The method of claim 1 , wherein the transdermal delivery device provides to the subject an average absorbed amount of dexmedetomidine over 72 hours from 100 μg to 400 μg.

15 . The method of claim 1 , wherein the transdermal delivery device provides to the subject an average area under the plasma dexmedetomidine concentration curve over 72 hours from 3,000 h×pg/mL to 10,000 h×pg/mL.

16 . The method of claim 1 , wherein the transdermal delivery device provides to the subject a peak flux from 0.6 μg/cm 2 /hr to 5 μg/cm 2 /hr.

17 . The method of claim 16 , wherein peak flux is reached from 2 to 24 hours after applying the transdermal delivery device to the skin surface of the subject.

18 . The method of claim 1 , wherein the transdermal delivery device provides to the subject a steady state average flux of dexmedetomidine of from about 0.005 to 2 μg/cm 2 /hr at 24 hours after applying the transdermal delivery device to the skin surface of the subject.

19 . The method of claim 1 , wherein the amount of post-operative pain reduction is measured by the Numeric Pain Rating Scale, and the method reduces the rating of the Numeric Pain Rating Scale by about 1 over at least 72 hours after the surgery.

Assignments (1)

Continuity (3)

References Cited (248)