COMPOSITIONS AND METHODS FOR TREATING ROSACEA AND ACNE

• US 20200016068A1
• Filed: 07/11/2019
• Published: 01/16/2020
• Est. Priority Date: 09/08/2016
• Status: Active Grant

• Current Assignee: Journey Medical Corp. (Fortress Biotech, Inc.)
• Original Assignee: Foamix Pharmaceuticals, Ltd. (VYNE Therapeutics, Inc.)
• Inventors: Tamarkin, Dov, Eini, Meir, Hazot, Yohan, Shirvan, Mitchell, Kedem, Tal Hetzroni, Keynan, Rita
• Granted Patent: US 10,849,847 B2
• Time in patent office: Days
• CPC Class Codes: A61K 31/65 Tetracyclines
• CPC Class Codes: A61K 47/06 Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/24 containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
• CPC Class Codes: A61K 47/44 Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14
• CPC Class Codes: A61K 47/46 Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/122 Foams; Dry foams edible foams A61K9/0056
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 7/00 Drugs for disorders of the blood or the extracellular fluid

Abstract

Provided are compositions and methods for treating rosacea and acne. Specifically, a gel or foam composition having a tetracycline antibiotic and uses thereof for treating rosacea and acne are provided.

Claims

1-228. -228. (canceled)

229. A method for treating acne vulgaris in a subject in need thereof, comprising topically administering to the subject a therapeutically effective amount of a breakable foam obtained from a foamable composition once daily for at least seven consecutive days, wherein the foamable composition comprises:

(a) a hydrophobic vehicle comprising;

(i) about 70% to about 90% by weight of a hydrophobic solvent comprising;

about 35% w/w to about 65% w/w of soybean oil;

about 16.5% w/w to about 30.7% w/w of coconut oil;

about 3.5% w/w to about 6.5% w/w of cyclomethicone; and

about 1% w/w to about 6% w/w of light mineral oil; and

(ii) about 10% to about 22% by weight of a foamer complex comprising;

about 2.5% w/w to about 4.6% w/w of cetostearyl alcohol;

about 2% w/w to about 4% w/w of stearic acid;

about 1.8% w/w to about 3.3% w/w of myristyl alcohol;

about 1% w/w to about 3% w/w of hydrogenated castor oil;

about 1% w/w to about 3% w/w of beeswax;

about 1% w/w to about 2% w/w of stearyl alcohol; and

about 0.5% w/w to about 1.5% w/w of behenyl alcohol;

(iii) minocycline in an amount ranging from about 1% w/w to about 4% w/w; and

(b) a propellant in an amount ranging from about 3% to about 25% w/w; and

wherein the subject is between 15 years old and 16 years and 11 months old.

230. The method of claim 229, wherein the minocycline is present in plasma from the subject at a concentration of about 1.9 ng/mL before applying the seventh day of treatment with the therapeutically effective amount of the foam.

231. The method of claim 229, wherein the minocycline is present in plasma from the subject at a concentration of about 1.8 ng/mL 3 hours after applying the seventh day of treatment with the therapeutically effective amount of the foam.

232. The method of claim 229, wherein the minocycline is present in plasma from the subject at a concentration of about 1.8 ng/mL 12 hours after applying the seventh day of treatment with the therapeutically effective amount of the foam.

233. The method of claim 229, wherein the minocycline is present in plasma from the subject at a concentration of about 1.6 ng/mL 16 hours after applying the seventh day of treatment with the therapeutically effective amount of the foam.

234. The method of claim 229, wherein the minocycline is present in plasma from the subject at a concentration of about 1.5 ng/mL 24 hours after applying the seventh day of treatment with the therapeutically effective amount of the foam.

235. The method of claim 229, wherein a maximum measured plasma concentration in the subject is reached about 6 hours after a daily topical administration.

236. The method of claim 229, wherein the foamable composition does not comprise silicon dioxide (SiO₂).