Abstract: Provided herein are gastroretentive dosage forms (GRDFs) for extended retention in a human stomach, comprising a body comprising at least two arms, the body configured to transform between a collapsed configuration for ingestion, an expanded configuration for retention within the stomach and a disassembled configuration wherein after a predetermined time period has elapsed, the GRDF disassembles into at least two parts such that each of the disassembled parts of the GRDF is sized for exiting the stomach; and, an erodible insert comprising a therapeutic agent, a diagnostic agent, an electronical device, or a combination thereof.

Abstract: The present invention provides a method for safe and efficacious administration of esketamine.

Abstract: The present disclosure related to methods of treating pruritus in a subject by topically administering detomidine, or a pharmaceutically acceptable salt thereof, to the subject.

Abstract: The present invention provides a method for safe and efficacious administration of esketamine.

Abstract: Described are immediate release oral dosage forms that contain abuse-deterrent features. In particular, the disclosed dosage forms provide deterrence of abuse by ingestion of multiple individual doses. In addition, the disclosed dosage forms provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses.

Abstract: The present disclosure relates to a purified detomidine HCl pharmaceutical product and to methods of preparation, validation of pharmaceutically acceptable product and use thereof.

Abstract: Disclosed herein are immediate release oral dosage forms that contain abuse-deterrent and abuse-resistant features. In particular, the disclosed dosage forms can provide deterrence of abuse by ingestion of multiple individual doses. The disclosed dosage forms can likewise provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses. The dosage forms may also exhibit abuse resistant properties when physically manipulated, and also when physically manipulated and then administered in a manner not consistent with oral dosing. The dosage forms may also exhibit abuse resistant properties when administered in a manner intended to result in administration of the esketamine in a higher than therapeutic dose.

Abstract: Described are immediate release oral dosage forms that contain abuse-deterrent features. In particular, the disclosed dosage forms provide deterrence of abuse by ingestion of multiple individual doses. In addition, the disclosed dosage forms provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses.

Abstract: 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.

Abstract: An oral gastro-retentive delivery device is provided which unfolds rapidly upon contact with gastric juice. The device is configured in a collapsed configuration for oral intake and unfolding for gastric retention for a predetermined period of time and eventually reducing in size for passage through the rest of the GI track.

Abstract: The present disclosure is in the field of gastric resident systems. A device for extended retention in a stomach is provided. The device includes: first, second, and third arms, the second and third arms being pivotally connected to respective ends of the first arm. The device is configured to transform between a compressed configuration and an expanded configuration. The device further includes a biasing member configured to bias the device into the expanded configuration whereby the second and third arms are configured to mechanically engage each other to retain the system in the expanded configuration.

Abstract: The present disclosure is in the field of gastroretentive dosage forms. A gastroretentive dosage form for extended retention in a stomach is provided.

Abstract: Described are immediate release oral dosage forms that contain abuse-deterrent features. In particular, the disclosed dosage forms provide deterrence of abuse by ingestion of multiple individual doses. In addition, the disclosed dosage forms provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses.

Abstract: Provided are methods and compositions for treating nocturnal symptoms of Parkinson's disease, morning akinesia, or associated symptoms thereof in a human subject in need thereof, wherein circulating plasma levels of levodopa are provided for an extended period of time following a period of delay after administration.

Abstract: Provided are methods and compositions for treating nocturnal symptoms of Parkinson's disease, morning akinesia, or associated symptoms thereof in a human subject in need thereof, wherein circulating plasma levels of levodopa are provided for an extended period of time following a period of delay after administration.

Abstract: Disclosed herein are immediate release oral dosage forms that contain abuse-deterrent and abuse-resistant features. In particular, the disclosed dosage forms can provide deterrence of abuse by ingestion of multiple individual doses. The disclosed dosage forms can likewise provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses. The dosage forms may also exhibit abuse resistant properties when physically manipulated, and also when physically manipulated and then administered in a manner not consistent with oral dosing. The dosage forms may also exhibit abuse resistant properties when administered in a manner intended to result in administration of the esketamine in a higher than therapeutic dose.

Abstract: An oral gastro-retentive delivery device is provided which unfolds rapidly upon contact with gastric juice. The device is configured in a collapsed configuration for oral intake and unfolding for gastric retention for a predetermined period of time and eventually reducing in size for passage through the rest of the GI track.

Abstract: The present invention provides a method for safe and efficacious administration of esketamine.

Abstract: The disclosure is directed to fibrous structures finished with active pharmaceutical ingredients, as well as methods of their manufacturer and use.

Abstract: Provided are devices that are configured for gastric retention for a period of at least six hours (or at least three hours if the subject is in the fasted state) while maintaining their structural integrity and releasing or holding an active or diagnostic agent into or in gastric fluid of a human subject over that period, as well as methods of delivering an agent over an extended period by orally administering such devices to a subject, uses of an enteric polymer in the formation of devices that deliver an agent over an extended period of time, and methods of making such devices.