# US 9,867,799 B2 · Diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride for use in the treatment of muscular dystrophy > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,867,799 B2 - Document ID: US9867799B2 - Status: Granted - Kind: B2 - Application number: 15/208,957 - Filed: 2016-07-13 - Published: 2016-12-01 - Granted: 2018-01-16 - Earliest claimed: 2012-02-03 - Assignees: Italfarmaco S.p.A. - Applicants: Italfarmaco S.P.A. - Inventors: Valentina Saccone; Silvia Consalvi; Pier Lorenzo Puri; Paolo Mascagni - Web page: https://patentgrep.com/patent/US9867799B2 ## CPC - A61K 31/27: of carbamic or thiocarbamic acids, meprobamate, carbachol, neostigmine - A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)} - A61K 31/167: having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol - A61K 31/325: Carbamic acids; Thiocarbamic acids; Anhydrides or salts thereof (thiurams A61K31/145) - A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone - A61K 31/58: containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048}) - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 21/00: Drugs for disorders of the muscular or neuromuscular system - A61P 21/04: for myasthenia gravis - A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - 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 relates to a method for treating muscular dystrophy which comprises administering diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride or other pharmaceutically acceptable salts and/or solvates thereof to a patient in need of such a treatment. The invention further relates to a method for treating muscular dystrophy which comprises administering diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride or other pharmaceutically acceptable salts and/or solvates thereof in combination with one or more additional anti-inflammatory active agents to a patient in need of such a treatment. ## Claims ### Claim 1 A method for treating muscular dystrophy in a patient, comprising administering to a patient in need thereof active ingredients consisting of (i) diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphthalen-2-yl-methyl]-ammonium chloride, or the pharmaceutically acceptable salts and/or solvates thereof, and (ii) one additional anti-inflammatory agent. ### Claim 2 (depends on 1) The method according to claim 1, wherein said additional anti-inflammatory agent is a steroid. ### Claim 3 (depends on 2) The method according to claim 2, wherein said steroid is selected from the group consisting of prednisolone, prednisone, deflazacort, hydrocortisone, methylprednisolone, dexamethasone, betamethasone, triamcinolone, beclometasone, fludrocortisone acetate, and deoxycorticosterone acetate. ### Claim 4 (depends on 1) The method according to claim 1, wherein said diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphthalen-2-yl-methyl]-ammonium chloride, or the pharmaceutically acceptable salts and/or solvates thereof, and said additional anti-inflammatory agent are administered simultaneously, separately, or sequentially. ### Claim 5 (depends on 1) The method according to claim 1, wherein said muscular dystrophy is Duchenne muscular dystrophy. ### Claim 6 (depends on 1) The method according to claim 1, wherein the administration to the patient is on a daily basis. ### Claim 7 (depends on 1) The method according to claim 1, wherein said diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphthalen-2-yl-methyl]-ammonium chloride, or the pharmaceutically acceptable salts and/or solvates thereof is administered in an amount ranging from 0.5 to 15 mg/kg/day. ### Claim 8 (depends on 1) The method according to claim 1, wherein said patient is a child. ### Claim 9 (depends on 8) The method according to claim 8, wherein said diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphthalen-2-yl-methyl]-ammonium chloride, or the pharmaceutically acceptable salts and/or solvates thereof is administered in an amount ranging from 1 to 10 mg/kg/day. ### Claim 10 (depends on 1) The method according to claim 1, wherein said diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphthalen-2-yl-methyl]-ammonium chloride, or the pharmaceutically acceptable salts and/or solvates thereof is administered in the form of a pharmaceutical composition comprising the same together with at least one physiologically acceptable excipient. ### Claim 11 (depends on 10) The method according to claim 10, wherein said pharmaceutical composition is administered by oral, sublingual, rectal, intravascular, intravenous, or subcutaneous route. ### Claim 12 (depends on 11) The method according to claim 11, wherein said pharmaceutical composition is in a solid or a liquid form. ### Claim 13 (depends on 12) The method according to claim 12, wherein said solid form is selected from the group consisting of powder, tablet, granulate, aggregate, compressed pill, coated pill, hard gelatin capsule, and gelatin capsule. ### Claim 14 (depends on 12) The method according to claim 12, wherein said liquid form is a suspension or a syrup. ### Claim 15 (depends on 1) The method according to claim 1, wherein said diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphthalen-2-yl-methyl]-ammonium chloride is in a monohydrate form. ### Claim 16 (depends on 1) The method according to claim 1, wherein said diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphthalen-2-yl-methyl]-ammonium chloride is in a crystal form.