# US 2019/0167633 A1 · Combination therapy for effecting weight loss and treating obesity > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2019/0167633 A1 - Document ID: US20190167633A1 - Status: Published application - Kind: A1 - Application number: 16/026,886 - Filed: 2018-07-03 - Published: 2019-06-06 - Earliest claimed: 1999-06-14 - Assignees: Vivus, Inc. - Applicants: Vivus, Inc. - Inventors: Thomas NAJARIAN - Web page: https://patentgrep.com/patent/US20190167633A1 ## CPC - A61K 31/357: having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel - A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration} - A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone} - A61K 31/35: having six-membered rings with one oxygen as the only ring hetero atom - A61K 31/351: not condensed with another ring - A61K 31/535: having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines - A61K 31/7048: having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin {, digitoxin or digoxin} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 3/04: Anorexiants; Antiobesity agents - A61P 11/00: Drugs for disorders of the respiratory system - A61K 2300/00: Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00 - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present invention features a novel therapy for effecting weight loss which involves treating a subject with a sympathomimetic agent (e.g., phentermine or a phentermine-like drug) in combination with an anticonvulsant sulfamate derivative (e.g., topiramate) such that the subject experiences weight loss. The combination methods of the present invention also are effective against symptoms associated with Syndrome X. The invention also features pharmaceutical compositions and kits for use in the practice of these novel therapies. ## Claims ### Claim 1 A pharmaceutical composition formulated for oral administration comprising 25 mg to 100 mg of topiramate, formulated for controlled release, and 5 mg to 15 mg of phentermine, formulated for immediate release. ### Claim 2 (depends on 1) The pharmaceutical composition of claim 1 comprising 25 mg to 50 mg of topiramate, formulated for controlled release, and 5 mg to 8 mg of phentermine, formulated for immediate release. ### Claim 3 A method of effecting weight loss a subject need thereof by administering a pharmaceutical composition formulated for oral administration comprising 25 mg to 100 mg of topiramate, formulated for controlled release, and 5 mg to 15 mg of phentermine, formulated for immediate release. ### Claim 4 (depends on 3) The method of claim 3 comprising 25 mg to 50 mg of topiramate, formulated for controlled release, and 5 mg to 8 mg of phentermine, formulated for immediate release. ### Claim 5 (depends on 1) The pharmaceutical composition of claim 1, wherein the composition further comprises a pharmaceutically acceptable carrier. ### Claim 6 (depends on 1) The pharmaceutical composition of claim 1, wherein formulated for controlled release is formulated for delayed release. ### Claim 7 (depends on 6) The pharmaceutical composition of claim 6, wherein delayed release is delaying the release of topiramate for at least 4 hours following the release of phentermine. ### Claim 8 (depends on 1) The pharmaceutical composition of claim 1, wherein formulated for controlled release is formulated for sustained release. ### Claim 9 (depends on 8) The pharmaceutical composition of claim 8, wherein sustained release is providing topiramate over at least a 4 hour time period. ### Claim 10 (depends on 1) The pharmaceutical composition of claim 1, wherein the composition is a tablet, capsule, troche, suspension, syrup or wafer. ### Claim 11 (depends on 10) The pharmaceutical composition of claim 10, wherein the tablet, capsule or pill comprises a topiramate core in association with a layer of phentermine. ### Claim 12 (depends on 10) The pharmaceutical composition of claim 10, wherein the tablet, capsule or pill comprises at least a first layer comprising phentermine and at least a second layer comprising topiramate. ### Claim 13 (depends on 12) The pharmaceutical composition of claim 12, wherein the at least first layer is the outer most layer of the tablet, capsule or pill. ### Claim 14 (depends on 12) The pharmaceutical composition of claim 12, wherein the at least second layer is the core of the tablet, capsule or pill. ### Claim 15 (depends on 3) The method of claim 3, wherein the composition is administered for 5 to 9 months. ### Claim 16 (depends on 3) The method of claim 3, wherein the composition is administered for 12 to 18 months. ### Claim 17 (depends on 3) The method of claim 3, wherein the composition is administered for up to 18 months. ### Claim 18 (depends on 3) The method of claim 3, wherein the composition is administered until the subject has achieved a weight loss of at least 5% compared to the subject's weight prior to administration of the composition. ### Claim 19 (depends on 18) The method of claim 18, wherein the composition is administered until the subject has achieved a weight loss of 5-10%. ### Claim 20 (depends on 3) The method of claim 3, wherein the composition is administered until the subject has achieved a weight loss of at least 10% compared to the subject's weight prior to administration of the composition. ### Claim at position 21 21-23. (canceled)