Abstract: The present disclosure provides methods, systems, and devices for establishing dosing parameters for a drug administration device and establishing compatibility of components of the drug administration device. In an exemplary embodiment, a method can include acquiring data from a drug holder and communicating the data to a processor, communicating a relevant subset of dosing parameter data from a server to the processor, and establishing dosing parameters for a drug administration device based on the relevant subset of dosing parameter data. The relevant subset of dosing parameter data is determined based on the drug holder data. The method can include acquiring first component data relating to a first component of the drug administration device, comparing the first component data with acceptable first component data, and setting an operational status of the drug administration device based on the comparison.

Abstract: Various exemplary drug delivery devices (500, 700) with reusable components (512, 702) and disposable components (504, 704, 706), drug products utilizing the same, and methods of using drug delivery devices with reusable components and disposable components are provided. In general, a nasal drug delivery device is configured to deliver a drug therefrom and includes one or more disposable components and one or more reusable components. The one or more disposable components are releasably coupled to the one or more reusable components. After the drug is delivered from the drug delivery device, the one or more disposable components can be detached from the one or more reusable components. Another one or more disposable components can then be releasably coupled to the one or more reusable components and the drug delivery device used to again deliver a drug therefrom.

Abstract: Various exemplary drug delivery devices with a mechanical stop, drug products utilizing the same, and methods of using drug delivery devices with a mechanical stop are provided. In general, a nasal drug delivery device is configured to dispense therefrom first and second doses of a drug therefrom into a nose. The drug delivery device includes a mechanical stop configured to provide a pause between the delivery of the first and second doses. During the pause, a user of the drug delivery device can move the drug delivery device from one nostril, into which the first dose was sprayed, to another nostril, into which the second dose can be sprayed. The mechanical stop is configured to hold the drug delivery device in a static delivery state.

Abstract: Various exemplary drug holders (102, 200) for drug delivery devices (100), drug products utilizing the same, and methods of using drug holders for drug delivery devices are provided. In general, a nasal drug delivery device is configured to dispense therefrom at least one dose of a drug therefrom into a nose. The drug delivery device includes a drug holder that contains the drug therein that is delivered out of the drug delivery device. The drug holder can include two cavities (208, 210) therein that are fluidically sealed from one another prior to use of the drug delivery device to cause drug delivery. A first one of the cavities includes the drug therein, and a second one of the cavities includes a drug or air therein.

Abstract: Various exemplary drug delivery devices with on-board drug destruction, drug products utilizing the same, and methods of using drug delivery devices with on-board drug destruction are provided. In general, a nasal drug delivery device configured to dispense a drug therefrom into a nose includes a destruction mechanism configured to destroy drug contained in the drug delivery device. The destruction mechanism can be configured to destroy the drug before a first actuation of the drug delivery device to deliver the drug therefrom such that the destruction mechanism destroys substantially all of the drug contained in the drug delivery device. Alternatively or in addition, the destruction mechanism can be configured to destroy the drug after a first actuation of the drug delivery device to deliver the drug therefrom such that the destruction mechanism destroys substantially all of the drug remaining in the drug delivery device.

Abstract: Disclosed is a device for the parenteral delivery of a medication, such as a drug. The device includes upper and lower housings in which the upper housing is configured to move relative to the lower housing as a result of application of an external force to permit the user of the device to control the rate at which the drug is administered.

Abstract: Disclosed is a device for the parenteral delivery of a medication, such as a drug. The device includes upper and lower housings in which the upper housing is configured to move relative to the lower housing as a result of application of an external force to permit the user of the device to control the rate at which the drug is administered.

Abstract: The present invention is directed to pharmaceutical products, and to methods for the treatment of depression (e.g., major depressive disorder) and other diseases or disorders for which esketamine has a therapeutic benefit. In some embodiments, the methods are useful for the treatment of treatment-refractory or treatment-resistant depression or suicidal ideation. Methods of intranasal administration and devices for intranasal administration are also disclosed.

Abstract: A device configured to administer a medication can comprise a lower housing that includes a housing latch. The device can further comprise a needle guard that is movable relative to the lower housing along a first direction from a first position to a second position so as to expose a needle, and an upper housing supported relative to the lower housing. The upper housing can be configured to move with respect to the lower housing along a second direction from a pre-use position to a dispensed position. The housing latch can releasably interfere with the upper housing when the upper housing is in the pre-use position so as to prevent the upper housing from moving toward the dispensed position, and the movement of the needle guard toward the second position, causes the interference to be removed, thereby allowing the upper housing to move toward the second position.

Abstract: A device configured to administer a medication can comprise a lower housing that includes a housing latch. The device can further comprise a needle guard that is movable relative to the lower housing along a first direction from a first position to a second position so as to expose a needle, and an upper housing supported relative to the lower housing. The upper housing can be configured to move with respect to the lower housing along a second direction from a pre-use position to a dispensed position. The housing latch can releasably interfere with the upper housing when the upper housing is in the pre-use position so as to prevent the upper housing from moving toward the dispensed position, and the movement of the needle guard toward the second position, causes the interference to be removed, thereby allowing the upper housing to move toward the second position.

Abstract: In general, methods, systems, and devices for remote aggregation of data for drug administration devices are provided. In one exemplary embodiment, data indicative of information sensed with a sensor of a drug administration device can be wirelessly transmitted from a drug administration device to a server. The server can use the data to correlate the patients use of the drug with the patients clinical outcome, perform a cost analysis of the patients treatment, determine whether the drug was delivered to the patient in compliance with the patients treatment plan, identify a malfunction in the administration of the drug, determine that additional data is needed from the drug administration device and trigger a request for the additional data to be wirelessly transmitted from the server to the drug administration device, and/or predictively model the patients clinical outcome.

Abstract: In general, drug administration devices configured to communicate with networks and external devices are provided. In an exemplary embodiment, a drug administration device is configured to adjust an operational parameter of the drug administration device based on a data packet formed from drug administration data ancillary data received from networks and/or external devices. In another example embodiment, a drug administration device is configured to scan for and establish communications with at least one external device. In another example embodiment, a method includes assessing whether to update a control program on a drug administration device from a network or external device. In another example embodiment, a system includes a first drug administration device configured to communicate with a second drug administration device to optimize a drug treatment.

Abstract: The present invention is directed to pharmaceutical products, and to methods for the treatment of depression (e.g., major depressive disorder) and other diseases or disorders for which esketamine has a therapeutic benefit. In some embodiments, the methods are useful for the treatment of treatment-refractory or treatment-resistant depression or suicidal ideation. Methods of intranasal administration and devices for intranasal administration are also disclosed.

Abstract: The present disclosure relates to drug administration. In an exemplary embodiment, a system can include a drug administration device configured to dispense a drug to a patient, a monitoring device configured to log a delivery event of drug delivery from the drug administration device into the patient, and a sensor configured to sense a patient parameter following delivery of the drug into the patient. In another exemplary embodiment, a drug administration device can include a drug holder configured to hold a drug, a dispensing mechanism configured to dispense the drug, and a sensor configured to sense a patient parameter, and the drug administration device can be configured to locally activate the drug at a target location in the patient. In another exemplary embodiment, methods, devices, and systems are provided to assess when operation of a drug dispensing mechanism is complete and to confirm whether drug administration was successful.

Abstract: The present invention provides devices and methods for treating depression in a patient, comprising administering to the patient in need of the treatment a therapeutically effective amount of esketamine. In some embodiments, the depression is major depressive disorder or treatment resistant depression. In other embodiments, the therapeutically effective amount is clinically proven safe and/or effective. Also provided are methods to mitigate the risk or misuse or abuse of esketamine, instructions for use of the esketamine product, and methods for selling a drug product containing esketamine.

Abstract: A device configured to administer a medication can comprise a lower housing that includes a housing latch. The device can further comprise a needle guard that is movable relative to the lower housing along a first direction from a first position to a second position so as to expose a needle, and an upper housing supported relative to the lower housing. The upper housing can be configured to move with respect to the lower housing along a second direction from a pre-use position to a dispensed position. The housing latch can releasably interfere with the upper housing when the upper housing is in the pre-use position so as to prevent the upper housing from moving toward the dispensed position, and the movement of the needle guard toward the second position, causes the interference to be removed, thereby allowing the upper housing to move toward the second position.

Abstract: Disclosed is a device for the parenteral delivery of a medication, such as a drug. The device includes upper and lower housings in which the upper housing is configured to move relative to the lower housing as a result of application of an external force to permit the user of the device to control the rate at which the drug is administered.

Abstract: The present invention provides devices and methods for treating depression in a patient, comprising administering to the patient in need of the treatment a therapeutically effective amount of esketamine. In some embodiments, the depression is major depressive disorder or treatment resistant depression. In other embodiments, the therapeutically effective amount is clinically proven safe and/or effective. Also provided are methods to mitigate the risk or misuse or abuse of esketamine, instructions for use of the esketamine product, and methods for selling a drug product containing esketamine.

Abstract: A device configured to administer a medication can comprise a lower housing that includes a housing latch. The device can further comprise a needle guard that is movable relative to the lower housing along a first direction from a first position to a second position so as to expose a needle, and an upper housing supported relative to the lower housing. The upper housing can be configured to move with respect to the lower housing along a second direction from a pre-use position to a dispensed position. The housing latch can releasably interfere with the upper housing when the upper housing is in the pre-use position so as to prevent the upper housing from moving toward the dispensed position, and the movement of the needle guard toward the second position, causes the interference to be removed, thereby allowing the upper housing to move toward the second position.