Abstract: A gastroretentive, sustained-release dosage form including 5-hydroxytryptophan (5-HTP) as an active ingredient and low-dose carbidopa is described. For example, the dosage form can be provided as a bilayer tablet comprising a swelling layer and a modified release layer, where the 5-HTP and carbidopa are both included in the modified release layer. The dosage form provides for essentially parallel release of the 5-HTP and the carbidopa with, for instance, release of 80% of the 5-HTP and carbidopa at about 5 hours to about 12 hours.

Abstract: This invention relates to a crystalline 19-nor C3,3-disubstituted C21-pyrazolyl steroid of Formula (I), and compositions thereof. Also disclosed herein are methods of making the same and methods of using the same.

Abstract: This invention relates to a crystalline 19-nor C3,3-disubstituted C21-pyrazolyl steroid of Formula (I), and compositions thereof. Also disclosed herein are methods of making the same and methods of using the same.

Abstract: This invention relates to a 19-nor C3,3-disubstituted C21-pyrazolyl steroid of formula (I) and pharmaceutical compositions thereof. Also disclosed herein are methods of making the pharmaceutical compositions of the 19-nor C3,3-disubstituted C21-pyrazolyl steroid of formula (I) and methods of using the 19-nor C3,3-disubstituted C21-pyrazolyl steroid of formula (I) or crystalline solid forms, pharmaceutically acceptable salts, and pharmaceutically acceptable compositions thereof.

Abstract: A gastroretentive, sustained-release dosage form including 5-hydroxytryptophan (5-HTP) as an active ingredient and low-dose carbidopa is described. For example, the dosage form can be provided as a bilayer tablet comprising a swelling layer and a modified release layer, where the 5-HTP and carbidopa are both included in the modified release layer. The dosage form provides for essentially parallel release of the 5-HTP and the carbidopa with, for instance, release of 80% of the 5-HTP and carbidopa at about 5 hours to about 12 hours.

Abstract: Aspects of the invention include topical naloxone compositions for locally delivering naloxone to the skin of a subject. Topical compositions according to certain embodiments are storage stable non-aqueous topical compositions that include naloxone free base and a non-aqueous vehicle, wherein the compositions are substantially free of naloxone N-oxide. Also provided are methods of using the topical compositions to locally deliver naloxone to a subject, as well as kits containing the topical naloxone compositions.

Abstract: This invention relates to a 19-nor C3,3-disubstituted C21-pyrazolyl steroid of formula (I) and pharmaceutical compositions thereof. Also disclosed herein are methods of making the pharmaceutical compositions of the 19-nor C3,3-disubstituted C21-pyrazolyl steroid of formula (I) and methods of using the 19-nor C3,3-disubstituted C21-pyrazolyl steroid of formula (I) or crystalline solid forms, pharmaceutically acceptable salts, and pharmaceutically acceptable compositions thereof.

Abstract: A gastroretentive, sustained-release dosage form including 5-hydroxytryptophan (5-HTP) as an active ingredient and low-dose carbidopa is described. For example, the dosage form can be provided as a bilayer tablet comprising a swelling layer and a modified release layer, where the 5-HTP and carbidopa are both included in the modified release layer. The dosage form provides for essentially parallel release of the 5-HTP and the carbidopa with, for instance, release of 80% of the 5-HTP and carbidopa at about 5 hours to about 12 hours.

Abstract: This disclosure provides, among other things, compositions comprising quantities of oltipraz crystals, as well as method of making such compositions, and method of treating patients using such compositions. Taste-modified compositions also are provided.

Abstract: This disclosure provides, among other things, compositions comprising quantities of oltipraz crystals, as well as method of making such compositions, and method of treating patients using such compositions.

Abstract: Aspects of the invention include transdermal delivery devices for delivering a tropane active agent to a subject. Also provided are methods of using the subject transdermal delivery devices, as well as kits containing one or more of the transdermal delivery devices.

Abstract: This invention relates to a crystalline 19-nor C3,3-disubstituted C21-pyrazolyl steroid of Formula (I), and compositions thereof. Also disclosed herein are methods of making the same and methods of using the same.

Abstract: The disclosure provides, inter alia, pharmaceutical compositions comprising micronized drug particles of adenosine A2A receptor antagonists, and methods of treating cancer using the pharmaceutical compositions.

Abstract: This invention relates to a 19-nor C3,3-disubstituted C21-pyrazolyl steroid of Formula (I) and crystalline solid forms and compositions thereof. Also disclosed herein are methods of making crystalline solid forms of the 19-nor C3,3-disubstituted C21-pyrazolyl steroid of Formula (I) and methods of using the 19-nor C3,3-disubstituted C21-pyrazolyl steroid of Formula (I) or crystalline solid forms, pharmaceutically acceptable salts, and pharmaceutically acceptable compositions thereof.

Abstract: This disclosure provides, among other things, compositions comprising quantities of oltipraz crystals, as well as method of making such compositions, and method of treating patients using such compositions. Taste-modified compositions also are provided.

Abstract: Aspects of the invention include methods for applying to a subject a transdermal delivery device configured to deliver a non-sedative amount of a dexmedetomidine composition. In practicing methods according to certain embodiments, a non-sedative amount of a dexmedetomidine composition is transdermally applied to a subject and is maintained in contact with the subject in a manner sufficient to deliver a non-sedative amount of dexmedetomidine to a subject. Also provided are transdermal delivery devices having a non-sedative amount of dexmedetomidine sufficient for practicing the subject methods, as well as kits containing the transdermal delivery devices.

Abstract: The disclosure provides, inter alia, pharmaceutical compositions comprising micronized drug particles of adenosine A2A receptor antagonists, and methods of treating cancer using the pharmaceutical compositions.

Abstract: Aspects of the invention include methods of treating ADHD, anxiety or insomnia by applying a transdermal delivery device containing a dexmedetomidine composition formulated to deliver an amount of dexmedetomidine to a subject diagnosed as having ADHD, anxiety or insomnia. In practicing methods according to certain embodiments, a transdermal delivery device having a dexmedetomidine composition is applied to a subject and is maintained in contact with the subject in a manner sufficient to deliver an amount of dexmedetomidine sufficient to treat ADHD, anxiety or insomnia in the subject. Also provided are transdermal delivery devices configured to deliver an amount of dexmedetomidine sufficient for practicing the subject methods, as well as kits containing the transdermal delivery devices.

Abstract: Aspects of the invention include transdermal delivery devices for delivering dexmedetomine to a subject, where the transdermal delivery devices include a single layer matrix dexmedetomine composition. Transdermal delivery devices according to certain embodiments include dexmedetomidine and a pressure sensitive adhesive provided as a single layer formulation. Also provide are methods of using the subject transdermal delivery devices to deliver dexmedetomidine to a subject, as well as kits containing the transdermal delivery devices.

Abstract: Topical sphingosine-1-phosphate receptor agonist active agent formulations are provided. Aspects of the transdermal formulations include an amount of a sphingosine-1-phosphate receptor agonist active agent in combination with a topical delivery vehicle, e.g., a topical patch that includes an adhesive layer and a backing layer. Also provided are methods of topically delivering a therapeutically effective amount of a sphingosine-1-phosphate receptor agonist active agent to a subject, e.g., to treat a subject for a disease condition, such as an immune system disorder like multiple sclerosis, a hyperproliferative dermatological disorder, e.g., psoriasis, acne, etc. Packaged topical formulations, kits including such formulations, and methods of making such formulations are also provided.