# US 12,178,810 B2 · Tesofensine and metoprolol for treatment of hypertension

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- Number: US 12,178,810 B2
- Document ID: US12178810B2
- Status: Granted
- Kind: B2
- Application number: 17/116,849
- Filed: 2020-12-09
- Published: 2021-04-01
- Granted: 2024-12-31
- Earliest claimed: 2016-01-15
- Assignees: Saniona A/S
- Applicants: Saniona A/S
- Inventors: Berit Edsberg; Thomas Amos Jacobsen
- Web page: https://patentgrep.com/patent/US12178810B2

## CPC

- A61K 31/46: 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
- A61K 31/138: Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine (atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377)
- A61P 9/12: Antihypertensives
- 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 relates to treatment of hypertension using a combination of tesofensine and metoprolol. The treatment is particularly well suited for the treatment of hypertensive obese subjects and hypertensive diabetic subjects.

## Claims

### Claim 1

A method for treating hyperphagia in a subject having Prader Willi Syndrome comprising orally administering to the subject
0.1 mg to 1 mg of tesofensine or a pharmaceutically acceptable salt thereof; and
10 mg to 200 mg of metoprolol or a pharmaceutically acceptable salt thereof.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the tesofensine or a pharmaceutically acceptable salt thereof and the metoprolol or a pharmaceutically acceptable salt thereof are administered simultaneously, sequentially or separately.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the tesofensine or a pharmaceutically acceptable salt thereof and the metoprolol or a pharmaceutically acceptable salt thereof are co-administered as a single pharmaceutical composition.

### Claim 4 (depends on 3)

The method according to claim 3, wherein the single pharmaceutical composition comprises
a first composition comprising an extended release (ER) composition of metoprolol or a pharmaceutically acceptable salt thereof,
a second composition comprising tesofensine or a pharmaceutically acceptable salt thereof, and
a third composition comprising an immediate release (IR) composition with metoprolol or a pharmaceutically acceptable salt thereof.

### Claim 5 (depends on 3)

The method according to claim 3, wherein the single pharmaceutical composition is in the form of a capsule.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the tesofensine or a pharmaceutically acceptable salt thereof is administered to said subject at a dose of 0.25 mg to 0.75 mg of tesofensine per day.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the metoprolol or a pharmaceutically acceptable salt thereof is administered to said subject at a dose of 25 mg to 100 mg of metoprolol per day.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the subject is an adult human.

### Claim 9 (depends on 8)

The method according to claim 8, wherein the subject has a body mass index (BMI) of 25 kg/m2 or a BMI of above 25 kg/m2, prior to the administration.

### Claim 10 (depends on 8)

The method according to claim 8, wherein the administration results in reduction of the subject's BMI, as compared to prior to the administration.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the subject is below 18 years of age.

### Claim 12 (depends on 11)

The method according to claim 11, wherein the administration results in decrease of the subject's waist circumference, as compared to prior to the administration.