Disclosed is a single unit oral dosage form having, in combination, inositol and an extended release clonidine or extended release guanfacine. In one aspect, a method for treating ADHD and/or associated symptoms thereof includes administering to an ADHD patient the single unit oral dosage form. In another aspect, a method for treating ADHD and/or associated symptoms thereof includes administering to an ADHD patient inositol in combination with extended release clonidine or extended release guanfacine, whether administered separately or as a single dosage form.

The present invention is directed to an implantable drug depot useful for reducing, preventing or treating post-operative pain in a patient in need of such treatment, the implantable drug depot comprising a therapeutically effective amount of clonidine or pharmaceutically acceptable salt thereof and a polymer; wherein the depot is implantable at a site beneath the skin to reduce, prevent or treat post-operative pain, and the depot is capable of releasing (i) about 5% to about 45% of the clonidine or pharmaceutically acceptable salt thereof relative to a total amount of the clonidine or pharmaceutically acceptable salt thereof loaded in the drug depot over a first period of up to 48 hours and (ii) about 55% to about 95% of the clonidine or pharmaceutically acceptable salt thereof relative to a total amount of the clonidine or pharmaceutically acceptable salt thereof loaded in the drug depot over a subsequent period of at least 3 days.

The present invention is directed to an implantable drug depot useful for reducing, preventing or treating post-operative pain in a patient in need of such treatment, the implantable drug depot comprising a therapeutically effective amount of clonidine or pharmaceutically acceptable salt thereof and a polymer; wherein the depot is implantable at a site beneath the skin to reduce, prevent or treat post-operative pain, and the depot is capable of releasing (i) about 5% to about 45% of the clonidine or pharmaceutically acceptable salt thereof relative to a total amount of the clonidine or pharmaceutically acceptable salt thereof loaded in the drug depot over a first period of up to 48 hours and (ii) about 55% to about 95% of the clonidine or pharmaceutically acceptable salt thereof relative to a total amount of the clonidine or pharmaceutically acceptable salt thereof loaded in the drug depot over a subsequent period of at least 3 days.

A transdermal drug delivery system is provided that includes a drug-in-adhesive matrix layer and a backing layer. The matrix layer includes an active pharmaceutical ingredient, a cross-linked polyvinylpyrrolidone binder, a mesoporous silicon dioxide filler, and a pressure sensitive adhesive, while the backing layer forms an exterior facing-surface of the delivery system. The ratio of the mesoporous silicon dioxide filler to the cross-linked polyvinylpyrrolidone binder ranges from about 1:1 to about 1:8. As a result of the specific components of the matrix layer and the amounts in which they are utilized, the resulting delivery system, which can include a homogeneous dispersion of the active pharmaceutical ingredient in the formulation, is capable of delivering the active pharmaceutical ingredient over a period of up to about 7 days in a generally constant and controlled fashion. Further, the only layer that contemplates the use of an adhesive component is the drug-in-adhesive matrix layer.

A transdermal drug delivery system is provided that includes a drug-in-adhesive matrix layer and a backing layer. The matrix layer includes an active pharmaceutical ingredient, a cross-linked polyvinylpyrrolidone binder, a mesoporous silicon dioxide filler, and a pressure sensitive adhesive, while the backing layer forms an exterior facing-surface of the delivery system. The ratio of the mesoporous silicon dioxide filler to the cross-linked polyvinylpyrrolidone binder ranges from about 1:1 to about 1:8. As a result of the specific components of the matrix layer and the amounts in which they are utilized, the resulting delivery system, which can include a homogeneous dispersion of the active pharmaceutical ingredient in the formulation, is capable of delivering the active pharmaceutical ingredient over a period of up to about 7 days in a generally constant and controlled fashion. Further, the only layer that contemplates the use of an adhesive component is the drug-in-adhesive matrix layer.

Disclosed herein are topical formulations comprising about 0.001 to about 3 wt % detomidine or a salt thereof; and, a carrier that is suitable for topical administration to a subject's skin, wherein the carrier optionally comprises a water-miscible solubilizer that is present in an amount of up to 40% by weight of the formulation; wherein the formulation has a pH of 4.5 to 9, and, wherein the formulation provides prolonged, substantially non-systemic treatment for pain. Also provided are methods for providing prolonged, non-systemic treatment for pain in a subject in need thereof comprising topically administering to the subject the presently disclosed topical formulations.

An oral clonidine dosage unit providing a twenty-four hour extended release profile following a single dose administration is provided. The dosage unit comprises a pharmaceutically effective amount of a coated complex comprising clonidine bound to a cationic exchange resin, which is characterized by a twenty-four hour release profile with a single peak, wherein said oral clonidine dosage unit provides a therapeutically effective plasma concentration for at least about 70%, or at least 85% of the twenty-four hour period following the single dose administration. Both liquid and solid formulations are provided, as are methods of treating a patient by a single administration of a formulation of the invention so as to achieve a therapeutic effect for 24-hours.

An oral clonidine dosage unit providing a twenty-four hour extended release profile following a single dose administration is provided. The dosage unit comprises a pharmaceutically effective amount of a coated complex comprising clonidine bound to a cationic exchange resin, which is characterized by a twenty-four hour release profile with a single peak, wherein said oral clonidine dosage unit provides a therapeutically effective plasma concentration for at least about 70%, or at least 85% of the twenty-four hour period following the single dose administration. Both liquid and solid formulations are provided, as are methods of treating a patient by a single administration of a formulation of the invention so as to achieve a therapeutic effect for 24-hours.

The present invention relates to the treatment of cancer. In particular, the invention relates to the therapeutic use of alpha-2 adrenergic receptor agonists for the treatment of cancer. More particularly, apraclonidine, clonidine, guanfacine and guanabenz, which are alpha-2 adrenergic receptor agonists, are all capable of efficiently reducing the growth of solid tumors. The effect is immune-mediated and is abolished in the presence of an alpha-2 antagonist or in mice that are knockout for the alpha-2 adrenergic receptor.

The present invention relates to the treatment of cancer. In particular, the invention relates to the therapeutic use of alpha-2 adrenergic receptor agonists for the treatment of cancer. More particularly, apraclonidine, clonidine, guanfacine and guanabenz, which are alpha-2 adrenergic receptor agonists, are all capable of efficiently reducing the growth of solid tumors. The effect is immune-mediated and is abolished in the presence of an alpha-2 antagonist or in mice that are knockout for the alpha-2 adrenergic receptor.