Abstract: The present disclosure relates to pharmaceutical compositions of dexpramipexole, or a pharmaceutically acceptable salt thereof. In particular, the present disclosure relates to pharmaceutical compositions in the form of orally deliverable tablets. The pharmaceutical compositions of the present disclosure provide for a sustained release of dexpramipexole, or a pharmaceutically acceptable salt thereof. In certain embodiments, the pharmaceutical compositions of the present disclosure additionally provide for an immediate release of dexpramipexole, or a pharmaceutically acceptable salt thereof. The present disclosure further relates to methods of manufacturing the pharmaceutical compositions, and methods of using the pharmaceutical compositions to treat and prevent certain diseases, such as eosinophilic disorders, in a human subject.

Abstract: A method of treating inadequately controlled severe asthma of the eosinophilic phenotype in a human subject in need thereof is disclosed. The method comprises orally administering to the subject a daily dose of about 150 mg to about 300 mg of dexpramipexole, or a pharmaceutically acceptable salt thereof, wherein the subject is already receiving at least an inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA), thereby treating the inadequately controlled severe asthma. A method of treating inadequately controlled moderate to severe asthma of the eosinophilic phenotype in a human subject in need thereof is also disclosed. The method comprises orally administering to the subject a daily dose of about 150 mg to about 300 mg of dexpramipexole, or a pharmaceutically acceptable salt thereof, wherein the subject is already receiving at least an ICS and an LABA, thereby treating the inadequately controlled moderate to severe asthma.

Abstract: The present disclosure relates to sustained release pharmaceutical compositions of dexpramipexole, or a pharmaceutically acceptable salt thereof. In some aspects, the present disclosure relates to sustained release pharmaceutical compositions in the form of orally deliverable tablets. In some aspects, the sustained release pharmaceutical compositions of the present disclosure comprise one or more anionic polymers at specific amounts. In some aspects, the sustained release pharmaceutical compositions of the present disclosure comprise one or more neutral polymers at specific amounts. The present disclosure further relates to methods of manufacturing the sustained release pharmaceutical compositions (or intermediate products thereof) and methods of using the sustained release pharmaceutical compositions to treat and prevent certain diseases, such as eosinophilic disorders, in a human subject.

Abstract: The invention is directed to pharmaceutical compositions and methods for delivery of a therapeutic or diagnostic agent from one bodily compartment to one or more other bodily compartment by administering one of the following conjugates: a polymer having multiple functional groups at least one of which is covalently bound to a therapeutic or diagnostic agent, and at least one cell uptake promoter covalently bound to the therapeutic or diagnostic agent; or a polymer and at least one cell uptake promoter bound thereto; the polymer further comprising multiple functional groups at least one of which is covalently bound a therapeutic or diagnostic agent.

Abstract: The invention is directed to pharmaceutical compositions and methods for delivery of a therapeutic or diagnostic agent from one bodily compartment to one or more other bodily compartment by administering one of the following conjugates: a polymer having multiple functional groups at least one of which is covalently bound to a therapeutic or diagnostic agent, and at least one cell uptake promoter covalently bound to the therapeutic or diagnostic agent; or a polymer and at least one cell uptake promoter bound thereto; the polymer further comprising multiple functional groups at least one of which is covalently bound a therapeutic or diagnostic agent.

Abstract: The invention is directed to pharmaceutical compositions and methods for delivery of a therapeutic or diagnostic agent from one bodily compartment to one or more other bodily compartment by administering one of the following conjugates: a polymer having multiple functional groups at least one of which is covalently bound to a therapeutic or diagnostic agent, and at least one cell uptake promoter covalently bound to the therapeutic or diagnostic agent; or a polymer and at least one cell uptake promoter bound thereto; the polymer further comprising multiple functional groups at least one of which is covalently bound a therapeutic or diagnostic agent.

Abstract: The invention is directed to pharmaceutical compositions and methods for delivery of a therapeutic or diagnostic agent from one bodily compartment to one or more other bodily compartment by administering one of the following conjugates: a polymer having multiple functional groups at least one of which is covalently bound to a therapeutic or diagnostic agent, and at least one cell uptake promoter covalently bound to the therapeutic or diagnostic agent; or a polymer and at least one cell uptake promoter bound thereto; the polymer further comprising multiple functional groups at least one of which is covalently bound a therapeutic or diagnostic agent.