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Claims for Patent: 8,580,299

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Claims for Patent: 8,580,299

Title:Escalating dosing regimen for effecting weight loss and treating obesity
Abstract: The present invention is drawn to novel topiramate compositions as well as methods for effecting weight loss, e.g., in the treatment of obesity and related conditions, including conditions associated with and/or caused by obesity per se. The present invention features an escalating dosing regimen adapted for the administration of topiramate and optionally a sympathomimetic agent such as phentermine or bupropion, in the treatment of obesity and related conditions.
Inventor(s): Najarian; Thomas (Los Osos, CA), Tam; Peter Y. (Redwood City, CA), Wilson; Leland F. (Menlo Park, CA)
Assignee: Vivus, Inc. (Mountain View, CA)
Application Number:12/481,548
Patent Claims: 1. A method for effecting weight loss in a subject having a body mass index of at least 30 kg/m.sup.2 and a condition associated with obesity comprising administering an escalating unit dosage form comprising, (a) a first dosage form, comprising, 23 mg of topiramate, formulated for controlled release, and 3.75 mg of phentermine, formulated for immediate release, wherein the first dosage form is administered to the subject daily for 2 weeks; and (b) a second dosage form, comprising either, 46 mg of topiramate, formulated for controlled release, and 7.5 mg of phentermine, formulated for immediate release, or 92 mg of topiramate, formulated for controlled release, and 15 mg of phentermine, formulated for immediate release, wherein the topiramate formulated for controlled release reaches maximum plasma concentration (Cmax) at about 6 to about 10 hours (Tmax) after administration and exhibits a lower Cmax, than non-controlled release topiramate, without decreasing total drug exposure defined by the area under the concentration-time curve (AUC), enabling a reduction in side effects without compromising the efficacy of the treatment, and wherein the second dosage form is administered to the subject daily for at least 2 years, thereby effecting weight loss and treating the condition associated with obesity.

2. The method of claim 1, wherein the phentermine is phentermine hydrochloride, wherein the amount of phentermine hydrochloride in the first dosage form is about 4.92 mg, and wherein 4.92 mg of phentermine hydrochloride provides 3.75 mg of phentermine.

3. The method of claim 1, wherein the phentermine is phentermine hydrochloride, wherein the amount of phentermine hydrochloride in the second dosage form is about 9.84 mg, and wherein 9.84 mg of phentermine hydrochloride provides 7.5 mg of phentermine.

4. The method of claim 1, wherein the condition associated with obesity is selected from the group consisting of diabetes, elevated fasting blood glucose, insulin resistance, impaired glucose tolerance, pulmonary hypertension, asthma, shortness of breath, gallbladder disease, dyslipidemia, high cholesterol, high levels of triglycerides, osteoarthritis, reflux esophagitis, sleep apnea, menstrual irregularities, infertility, complications in pregnancy, gout, high blood pressure, hypertension, coronary artery disease, heart disease, muscular dystrophy, stroke, thrombotic stroke, deep vein thrombosis (DVT), migraines, metabolic disorders, hypoalphalipoproteinemia, familial combined hyperlipidemia, Syndrome X, insulin-resistant Syndrome X, colon cancer, rectal cancer, renal cancer, esophageal cancer, gallbladder cancer, pancreatic cancer, prostate cancer, breast cancer, uterine cancer, ovarian cancer, endometrial cancer, and cervical cancer.

5. The method of claim 1, wherein the condition associated with obesity is selected from the group consisting of high blood pressure, high levels of triglycerides, elevated fasting blood glucose and diabetes.

6. The method of claim 1, wherein the subject is suffering from at least two conditions associated with obesity selected from the group consisting of high blood pressure, high levels of triglycerides, elevated fasting blood glucose and diabetes.

7. The method of claim 1, wherein the topiramate formulated for controlled release is formulated for sustained release, delayed release, or both.

8. The method of claim 1, wherein the escalating unit dosage form is formulated for oral administration.

9. The method of claim 1, wherein the weight loss is effective to achieve a reduction of at least about 10% of body weight.
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