Abstract: The subject invention provides an oral patch comprising: a) a liner; and b) a film composition thereon, the film composition comprising (i) laquinimod in an amount of about 0.1%-20% by weight of the film composition, and (ii) one or more film forming agents in a total amount of about 40%-90% by weight of the film composition. The subject invention also provides a method for delivering laquinimod across the oral mucosa of a subject, or for treating a human subject afflicted with a form of multiple sclerosis, comprising periodically administering to the human subject an oral patch as described herein. The subject invention also provides an oral patch as described herein for use in treating a human subject afflicted with a form of multiple sclerosis.

Abstract: The subject invention provides a pharmaceutical composition containing laquinimod or a pharmaceutically acceptable salt thereof, and a compound of N-ethyl-N-phenyl-1,2-dihydro-4,5-di-hydroxy-1-methyl-2-oxo-3-quinolinecarboxamide or a salt thereof.

Abstract: This application provides for a method of increasing brain-derived neurotrophic factor (BDNF) serum level in a human subject comprising periodically administering to the subject an amount of laquinimod or pharmaceutically acceptable salt thereof effective to increase BDNF serum level in the human subject. The method can further comprise periodically administering to the subject an amount of a second BDNF-increasing agent. This application also provides for a method for treating a human subject suffering from a BDNF-related disease comprising periodically administering laquinimod or a pharmaceutically acceptable salt thereof in an amount effective to treat the human subject. This application additionally provides for use of laquinimod in the manufacture of a medicament for increasing BDNF serum level in a human subject. This application further provides for a pharmaceutical composition comprising an amount of laquinimod effective for use in increasing BDNF serum level in a human subject.

Abstract: A stable pharmaceutical composition comprising a therapeutically effective amount of laquinimod, a therapeutically effective amount of glatiramer acetate related drug substance, and an amount of an amino acid. A process for making a stable pharmaceutical in liquid form, a sealed package comprising a stable pharmaceutical composition as described herein, and a use of a stable pharmaceutical composition as described herein. A method for treating a subject afflicted with multiple sclerosis or presenting a clinically isolated syndrome, alleviating a symptom of multiple sclerosis in a subject afflicted with multiple sclerosis or presenting a clinically isolated syndrome, and/or providing neuroprotection to a subject in need thereof, comprising administering to the subject a composition as described herein.

Abstract: The subject invention provides a method of treating a subject afflicted with glaucoma, suffering from retinal ganglion cell (RGC) loss or damage, or elevated intraocular pressure (IOP), or of reducing RGC loss or damage, or reducing IOP in a subject, comprising administering to the subject an amount of laquinimod effective to treat the subject, to reduce RGC loss or damage, or to reduce IOP in the subject. Provide also is a pharmaceutical composition, a package and a therapeutic package for treating a subject afflicted with glaucoma.

Abstract: This application provides for a method of treating a subject suffering from Crohn's disease, the method comprising periodically administering to the subject an amount of laquinimod or pharmaceutically acceptable salt thereof effective to treat the subject. This application provides for use of laquinimod in the manufacture of a medicament for treating a subject suffering from Crohn's disease. This application also provides for a pharmaceutical composition comprising laquinimod for use in treating a subject suffering from Crohn's disease.

Abstract: This invention provides a method of treating a subject afflicted with multiple sclerosis or presenting a clinically isolated syndrome comprising administering to the subject laquinimod as an add-on therapy to or in combination with flupirtine. This invention also provides a package and a pharmaceutical composition comprising laquinimod and flupirtine for treating a subject afflicted with multiple sclerosis or presenting a clinically isolated syndrome. This invention also provides laquinimod for use as an add-on therapy or in combination with flupirtine in treating a subject afflicted with multiple sclerosis or presenting a clinically isolated syndrome. This invention further provides use of laquinimod and flupirtine in the preparation of a combination for treating a subject afflicted with multiple sclerosis or presenting a clinically isolated syndrome.

Abstract: An inhaler for inhalation into the airway of a user, the inhaler having a housing at least partially defining a flow passageway extending through the inhaler from an air inlet to an outlet, the inhaler including a valve for selectively restricting the flow passageway.

Abstract: This invention provides a method of treating a patient afflicted with multiple sclerosis or presenting a clinically isolated syndrome comprising administering to the patient laquinimod as an add-on therapy to or in combination with glatiramer acetate. This invention also provides a package and a pharmaceutical composition comprising laquinimod and glatiramer acetate for treating a patient afflicted with multiple sclerosis or presenting a clinically isolated syndrome. This invention also provides laquinimod for use as an add-on therapy or in combination with glatiramer acetate in treating a patient afflicted with multiple sclerosis or presenting a clinically isolated syndrome. This invention further provides use of laquinimod and glatiramer acetate in the preparation of a combination for treating a patient afflicted with multiple sclerosis or presenting a clinically isolated syndrome.

Abstract: This invention provides a method for treating a human subject afflicted with multiple sclerosis or a single clinical attack consistent with multiple sclerosis with a pharmaceutical composition comprising glatiramer acetate and a pharmaceutically acceptable carrier, comprising the steps of 1) identifying whether the human subject is a predicted responder to glatiramer acetate by determining the genotype of the subject at one or more single nucleotide polymorphisms (SNPs) selected from the group consisting of the SNPs in Group 1; and 2) administering the pharmaceutical composition comprising glatiramer acetate and a pharmaceutically acceptable carrier to the subject only if the subject is identified as a predicted responder to glatiramer acetate.

Abstract: This invention provides a method of treating a subject suffering from Crohn's disease, comprising periodically administering to the subject an amount of laquinimod or pharmaceutically acceptable salt thereof effective to treat the subject, which amount of laquinimod is less than 0.5 mg/day, wherein the subject is naïve to laquinimod and the administration continues for at least 12 weeks, or wherein the subject is being treated with another Crohn's disease therapy at baseline. Furthermore, this invention provides a corresponding therapeutic package, use of laquinimod or pharmaceutically acceptable salt thereof in the manufacture of a medicament, and pharmaceutical composition.

Abstract: This invention provides a method of treating a subject afflicted with multiple sclerosis (MS) or presenting a clinically isolated syndrome (CIS) comprising administering to the subject laquinimod as an add-on therapy to or in combination with a greater than minimal effective dose of teriflunomide. This invention also provides a package and a pharmaceutical composition comprising laquinimod and a greater than minimal effective dose of teriflunomide for treating a subject afflicted with MS or presenting a CIS. This invention also provides laquinimod for use as an add-on therapy or in combination with a greater than minimal effective dose of teriflunomide in treating a subject afflicted with MS or presenting a CIS. This invention further provides use of laquinimod and a greater than minimal effective dose of teriflunomide in the preparation of a combination for treating a subject afflicted with MS or presenting a CIS.