Transmucosal drug delivery devices for use in chronic pain relief
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-009/00
A61K-031/485
출원번호
US-0724959
(2012-12-21)
등록번호
US-9901539
(2018-02-27)
발명자
/ 주소
Finn, Andrew
Vasisht, Niraj
출원인 / 주소
BioDelivery Sciences International, Inc.
대리인 / 주소
Womble Bond Dickinson (US) LLP
인용정보
피인용 횟수 :
0인용 특허 :
107
초록
Provided herein are methods for treating chronic pain by administering low doses of buprenorphine twice daily (or once daily) via a transmucosal drug delivery device. The methods and devices efficiently treat chronic pain without significant side effects.
대표청구항▼
1. A method of treating chronic pain, the method comprising: administering to a subject in need thereof a mucoadhesive bioerodable drug delivery device, wherein the device is administered once or twice daily,wherein the device comprises: a bioerodable mucoadhesive layer comprising about 100 g to abo
1. A method of treating chronic pain, the method comprising: administering to a subject in need thereof a mucoadhesive bioerodable drug delivery device, wherein the device is administered once or twice daily,wherein the device comprises: a bioerodable mucoadhesive layer comprising about 100 g to about 0.9 mg buprenorphine and buffered to a pH of between about 4.0 and about 6.0; anda backing layer buffered to a pH of between about 4.0 and about 4.8 and that does not include an opioid antagonist;wherein the device provides a steady-state Cmax of plasma buprenorphine concentration in a range between about 0.156 and about 0.364 ng/mL;wherein the subject is an opioid-experienced subject; andwherein the subject treated experiences mild or moderate common opioid adverse effects, or no common opioid adverse effects. 2. The method according to claim 1, wherein the device is administered once daily. 3. The method according to claim 1, wherein the chronic pain is chronic low back pain. 4. The method according to claim 1, wherein the chronic pain is moderate to severe chronic low back pain. 5. The method according to claim 1, wherein the subject is treated without significant constipation. 6. The method according to claim 1, wherein the subject is treated without significant nausea. 7. The method according to claim 1, wherein the total daily dose of buprenorphine administered to the subject is selected from the group consisting of 200 g, 220 g, 240 g, 280 g, 300 g, 320 g, 350 g, 360g, 400 g, 450 g, 480 g, 500 g, 550 g, 600 g, 620 g, 650 g, 700 g, 720 g, 750 g, 800 g, 860 g, 900 g, 960 g, 1000 g, 1100 g, 1200 g, 1250 g, 1300 g, 1400 g, 1500 g, 1600 g, and 1800 g of buprenorphine. 8. The method according to claim 1, wherein the mucoadhesive bioerodable drug delivery device further comprises a barrier layer comprising: a polymeric barrier environment disposed adjacent to the mucoadhesive layer to provide a unidirectional gradient upon application to a mucosal surface for the rapid and efficient delivery of buprenorphine,wherein the unidirectional gradient delivers buprenorphine across the buffered polymeric diffusion environment upon application to the mucosal surface. 9. A method of treating a subject with moderate to severe chronic low back pain, comprising: administering to the subject twice daily a mucoadhesive bioerodable drug delivery device to an oral mucosal surface of the subject, the device comprising: a bioerodable mucoadhesive layer comprising an effective amount of buprenorphine disposed in a buffered polymeric diffusion environment, wherein the polymeric diffusion environment is a buffered environment having a pH of between about 4 and about 6; anda backing layer buffered to a pH between about 4.0 and about 4.8 and that does not include an opioid antagonist;wherein the total daily dose of buprenorphine administered to the subject is effective for treating moderate to severe chronic low back pain; wherein the subject is an opioid-experienced subject; andwherein the subject treated experiences mild or moderate common opioid adverse effects, or no common opioid adverse effects. 10. The method according to claim 1, wherein said chronic pain is neuropathic pain. 11. The method according to claim 1, wherein said chronic pain is osteoarthritic pain. 12. The method according to claim 1, wherein the device comprises a dose of buprenorphine selected from the group consisting of 100 g, 110 g, 120 g, 140 g, 150 g, 160 g, 175 g, and 180g. 13. The method according to claim 1, wherein the total daily dose of buprenorphine administered to the subject ranges from 200 g to about 1800 μg. 14. The method according to claim 1, wherein steady-state Tmax of buprenorphine is in a range between about 2.00 and about 2.90 h. 15. The method according to claim 1, wherein Cmin of buprenorphine is in a range between about 0.0157 and about 0.0862 ng/mL. 16. The method according to claim 1, wherein steady-state AUClast of buprenorphine is in a range between about 0.4085 and about 5.033 h*ng/mL. 17. The method according to claim 1, wherein between about 2.4-6.9% of subjects experience drug related mild or moderate headaches as a treatment emergent adverse event (TEAE). 18. The method according to claim 1, wherein between about 3-6.9% of subjects experience drug related mild or moderate dizziness as a TEAE. 19. The method according to claim 1, wherein between about 2.6-27.9% of subjects experience drug related mild or moderate nausea as a TEAE. 20. The method according to claim 1, wherein between about 1.5-8.5% of subjects experience drug related mild or moderate constipation as a TEAE. 21. The method according to claim 1, wherein between about 0.9-3% of subjects experience drug related mild or moderate vomiting as a TEAE. 22. The method according to claim 1, wherein between about 7.7-33.9% of subjects experience drug related mild or moderate TEAEs.
연구과제 타임라인
LOADING...
LOADING...
LOADING...
LOADING...
LOADING...
이 특허에 인용된 특허 (107)
Lee Eun S. (Redwood City CA) Goetz Victor (Philadelphia PA), Abusable substance dosage form having reduced abuse potential.
Babaian Eduard A. (Moscow SUX) Gerasimova Galina A. (Moscow SUX) Davydov Anatoly B. (Moscow SUX) Utyamyshev Rustam I. (Moscow SUX) Khromov Gennady L. (Moscow SUX) Metelitsa Vladimir I. (Moscow SUX) V, Antianginal film and method of treating ischemic heart disease.
Rel Bernhard (Knigstein/Taunus DEX) Petri Walter (Niedernhausen/Taunus DEX), Base for mucosal and denture adhesive pastes, a process for the preparation thereof, and pastes having this base.
Schiraldi Michael T. (East Brunswick NJ) Perl Martin M. (Brooklyn NY) Rubin Howard (Rockaway NJ), Bioadhesive extruded film for intra-oral drug delivery and process.
Stanley Theodore H. (Salt Lake City UT) Hague Brian (West Valley City UT), Compositions of oral nondissolvable matrixes for transmucosal administration of medicaments.
Kim Jung J. (Anyang-shi KRX) Lee Woo Y. (Anyang-shi KRX) Ahn Jong W. (Seoul KRX) Han Sang H. (Suwon-shi KRX), Medicinal adhesive for percutaneous administration.
Wong Ooi (Fremont CA) Farinas Kathleen C. (San Francisco CA) Cleary Gary W. (Menlo Park CA) Chiang Chia-Ming (Foster City CA) Xia Jun (Redwood City CA), Method and device for providing nicotine replacement therapy transdermally/transbuccally.
Nagai Tsuneji (Chofu JPX) Machida Yoshiharu (Kawasaki JPX) Suzuki Yoshiki (Hino JPX) Ikura Hiroshi (Hino JPX), Method and preparation for administration to the mucosa of the oral or nasal cavity.
Nagai Tsuneji (Chofu JPX) Machida Yoshiharu (Kawasaki JPX) Suzuki Yoshiki (Hino JPX) Ikura Hiroshi (Hino JPX), Method and preparation for administration to the mucosa of the oral or nasal cavity.
Cilento Rodolfo D. (North Brunswick NJ) Frank Margaret A. (Lawrenceville NJ) Fairbrother John E. (Wales NJ GBX) Freeman Frank M. (Lawrenceville NJ), Method of preparing adhesive dressings containing a pharmaceutically active ingredient.
Suzuki Yoshiki (Hino JPX) Ikura Hiroshi (Hino JPX) Yamashita Gentaro (Tachikawa JPX) Nagai Tsuneji (Taito JPX), Method of treating an injured part on the oral mucosa and the covering material for use thereof.
Berner Bret (Scarsdale NY) Ebert Charles (Salt Lake City UT) Mazzenga Gerard C. (New City NY) Otte John H. (Monsey NY), Mixed solvent mutually enhanced transdermal therapeutic system.
Newsham E. A. (Derbyshire GBX) Forrester Jeffrey W. (Merseyside GBX) Rowley Duncan J. (Merseyside GBX), Moistureless oral drug delivery formulation and method for preparing same.
Moro, Daniel G.; Callahan, Howard; Nowotnik, David, Mucoadhesive erodible drug delivery device for controlled administration of pharmaceuticals and other active compounds.
Kizawa Hidenori (Tokyo JPX) Fujiyama Norimasa (Tokyo JPX) Kobayashi Jitsuo (Kanagawa JPX) Ito Akinori (Niigata JPX), Mucous membrane-adhering film preparation and process for its preparation.
Tucker Mark J. (Round Steps ; High Street Stow-on-the-Wold ; Gloucester GL54 1DL GBX) Tucker Mark R. (P.O. Box 23530 Bahrain BHX), Occlusive body for administering a physiologically active substance.
Penkler Lawrence John,ZAX ; De Kock Lueta-Ann,ZAX ; Whittaker Darryl Vanstone,ZAX, Pharmaceutical composition containing acid addition salt of basic drug.
Venkateshwaran Srinivasan ; Fikstad David ; Ebert Charles D., Pressure sensitive adhesive matrix patches for transdermal delivery of salts of pharmaceutical agents.
Suzuki Yoshiki (Hino JPX) Ikura Hiroshi (Hino JPX) Yamashita Gentaro (Koganei JPX), Slow-releasing medical preparation to be administered by adhering to a wet mucous surface.
Hsu, Tsung-Min; Macy, Russell; Luo, Eric C., Transdermal administration of pharmacologically active amines using hydroxide-releasing agents as permeation enhancers.
Heiber Sonia J. (Salt Lake City UT) Ebert Charles D. (Salt Lake City UT) Dave Sirish C. (Salt Lake City UT), Transmucosal delivery of macromolecular drugs.
Heiber Sonia J. (Salt Lake City UT) Ebert Charles D. (Salt Lake City UT) Dave Sirish C. (Salt Lake City UT), Transmucosal delivery of macromolecular drugs.
Biegajski James E. (Foster City CA) Venkatraman Subbu S. (Palo Alto CA) Scott Ann M. (Mountain View CA), Water-soluble pressure-sensitive mucoadhesive and devices provided therewith for emplacement in a mucosa-lined body cavi.
※ AI-Helper는 부적절한 답변을 할 수 있습니다.