US 12,201,629 B2
Method of treatment and dosage forms thereof
Alessandra Cipriano, Eastchester, NY (US); Salvatore Colucci, Stamford, CT (US); Stephen Harris, Weston, CT (US); Michele Hummel, Marlton, NJ (US); Donald Kyle, Yardley, PA (US); and Garth Whiteside, Yardley, PA (US)
Assigned to Purdue Pharma L.P., Stamford, CT (US)
Appl. No. 16/625,011
Filed by PURDUE PHARMA L.P., Stamford, CT (US)
PCT Filed Jun. 29, 2018, PCT No. PCT/US2018/040460
§ 371(c)(1), (2) Date Dec. 20, 2019,
PCT Pub. No. WO2019/006404, PCT Pub. Date Jan. 3, 2019.
Claims priority of provisional application 62/527,337, filed on Jun. 30, 2017.
Prior Publication US 2020/0215052 A1, Jul. 9, 2020
Int. Cl. A61K 31/485 (2006.01); A61K 9/00 (2006.01); A61K 31/4468 (2006.01)
CPC A61K 31/485 (2013.01) [A61K 9/0019 (2013.01); A61K 31/4468 (2013.01)] 14 Claims
 
1. A method of treating pain comprising administering to a patient in need thereof
(i) an effective amount of hydromorphone during an administration period 1 at a mean input rate (in mg/h) of hydromorphone during said administration period 1, wherein said mean input rate of hydromorphone is expressed as the equimolar amount of hydromorphone free base administered during said administration period 1 divided by the duration of said administration period 1,
(ii) another effective amount of buprenorphine during an administration period 2 at a mean input rate (in mg/h) of buprenorphine during said administration period 2, wherein said mean input rate of buprenorphine is expressed as the equimolar amount of buprenorphine free base administered during said administration period 2 divided by the duration of said administration period 2,
wherein the administration period 1 and the administration period 2 overlap by at least 75%,
and wherein the ratio of said mean input rate of buprenorphine to said mean input rate of hydromorphone is from about 1:200 to about 1:8000;
wherein hydromorphone is formulated in a composition for intravenous infusion for treating pain, and buprenorphine is formulated in a transdermal patch or in a composition for intravenous infusion for treating pain;
wherein analgesia produced by the hydromorphone to the patient is not impacted by the buprenorphine.