2016
DOI: 10.5455/bcp.20161027122045
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Comment on FDA's Breakthrough Therapy Designation of Intranasal Esketamine for the Treatment of Major Depressive Disorder with Imminent Risk of Suicide

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Cited by 4 publications
(3 citation statements)
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References 9 publications
(7 reference statements)
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“…Psychedelic-assisted psychotherapy refers to pairing psychedelic substances with psychotherapeutic interventions to maximize therapeutic outcomes. Research indicates that psychedelics and substances that induce non-ordinary states of consciousness can provide a significant reduction in symptoms, so much so that the U.S. Federal Drug Administration (FDA) has granted some medications Breakthrough Therapy designation (e.g., Thomas et al, 2016). This means that the substances have shown preliminary clinical evidence demonstrating that the drug may have an advantage over the currently available therapies (Federal Drug Administration [FDA], 2018).…”
Section: Introduction To Psychedelic-assisted Therapiesmentioning
confidence: 99%
“…Psychedelic-assisted psychotherapy refers to pairing psychedelic substances with psychotherapeutic interventions to maximize therapeutic outcomes. Research indicates that psychedelics and substances that induce non-ordinary states of consciousness can provide a significant reduction in symptoms, so much so that the U.S. Federal Drug Administration (FDA) has granted some medications Breakthrough Therapy designation (e.g., Thomas et al, 2016). This means that the substances have shown preliminary clinical evidence demonstrating that the drug may have an advantage over the currently available therapies (Federal Drug Administration [FDA], 2018).…”
Section: Introduction To Psychedelic-assisted Therapiesmentioning
confidence: 99%
“…The same may apply to esketamine, and could explain the reason for its rapid onset of action, and the continuation of its effects even after elimination of the drug from the body [27,30]. The intranasal form of esketamine has multiple positive benefits as opposed to other modes of administration, as it is less painful and invasive, while also having a greater bioavailability than oral form [30]. Figure 2 shows the proposed mechanism of action of esketamine.…”
Section: Pharmacological Basismentioning
confidence: 97%
“…Studies show that ketamine has a more direct stimulating action on BDNF and mTOR compared to oral antidepressants [ 27 , 29 ]. The same may apply to esketamine, and could explain the reason for its rapid onset of action, and the continuation of its effects even after elimination of the drug from the body [ 27 , 30 ]. The intranasal form of esketamine has multiple positive benefits as opposed to other modes of administration, as it is less painful and invasive, while also having a greater bioavailability than oral form [ 30 ].…”
Section: Reviewmentioning
confidence: 99%