Patent SG-11201408318R-A (SG)
Title: Compositions and methods for transmucosal absorption
Inventor: LEDERMAN SETH
IPC: A61K9/00
Filed: 2013-06-14
Abstract: (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 19 December 2013 (19.12.2013) WIPOIPCT (10) International Publication Number WO 2013/188847 A1 (51) International Patent Classification: A61K31/135 (2006.01) A61K 9/00 (2006.01) (21) International Application Number: (22) International Filing Date: (25) Filing Language: (26) Publication Language: PCT/US2013/046023 14 June 2013 (14.06.2013) English English (30) Priority Data: 61/660,593 15 June 2012 (15.06.2012) US 61/667,774 3 July 2012 (03.07.2012) US 61/725,402 12 November 2012 (12.11.2012) US 61/792,900 15 March 2013 (15.03.2013) US (71) Applicant (for all designated States except KM, US): TONIX PHARMACEUTICALS, INC. [US/US]; 509 Madison Avenue, Suite 306, New York, New York 10022 (US). (72) Inventors; and (71) Applicants (for US only): LEDERMAN, Seth [US/US]; 245 E. 93rd Street, Apt. 14E, New York, New York 10128 (US). REINER, Giorgio [IT/IT]; Via Rusconi 24, 1-22 100 Como (IT). (72) Inventor; and (71) Applicant : BRITTAIN, Harry [US/US]; 10 Charles Road, Milford, New Jersey 08848 (US). (74) Agents: HALEY, James F., Jr. et al.; Ropes & Gray LLP, 1211 Avenue of the Americas, New York, New York 10036-8704 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. [Continued on next page] (54) Title: COMPOSITIONS AND METHODS FOR TRANSMUCOSAL ABSORPTION l> 00 00 00 5000 • 4000 - 15) Q. 0\" .§ 3000 • Q. CD N 4.8 mg, sublingual 5 mg, oral 0 .o o o >> O ro £ tn _cp CL 2000 - 1000 - 0 - 0.0 0.5 1.0 1.5 Time, hr Figure 14b 2.0 2.5 (57) Abstract: The invention provides compositions and methods for adminis­ tering therapeutic compounds, specific­ ally cyclobenzaprine or amitryptyline, for transmucosal absorption, wherein the compositions contain a basifying agent in addition to the therapeutic agent. The compositions and methods have a number of surprising pharma­ cokinetic benefits over oral administra­ tion. Methods of treating fibromyalgia in human subject a are also provided. WO 2013/188847 A11 lllll llllllll II llllll III lllll lllll III III III lllll lllll lllll lllll llll lllll llll lllllll llll llll (84) Designated States (unless otherwise indicated, for every kind of regional protection available)'. ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, — TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Published: — with international search report (Art. 21(3)) before the expiration of the time limit for amending the claims and to be republished in the event of receipt of amendments (Rule 48.2(h))