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Efficacy and safety of esketamine nasal spray in addition to standard of care in patients with major depressive disorder who have active suicidal ideation with intent: A subgroup analysis of the Asian cohort of ASPIRE I (a randomized, double-blind, placebo-controlled study)

Hong JP, Malek AZA, Li CT, Paik JW, Sulaiman AH, Madriaga G, et al.

Asia Pac Psychiatry, 2023 Dec;15(4):e12548.
PMID: 37771084 DOI: 10.1111/appy.12548

This post-hoc analysis evaluated the efficacy and safety of intranasal esketamine in the Asian subgroup from ASPIRE I. Patients with major depressive disorder and suicidal ideation with intent received intranasal esketamine (n = 26) or placebo (n = 27), plus standard of care for 25 days. The primary endpoint was the change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to Day 2. The MADRS score improved in favor of esketamine (least squares mean difference: -3.8). No unexpected safety concerns were noted. The Asian subgroup showed a similar efficacy and safety profile as the total ASPIRE I cohort.

Matched MeSH terms: Nasal Sprays
Lidocaine/Phenylephrine Nasal Spray versus Nebulization Prior to Nasoendoscopy: A Randomized Controlled Trial

Goh LC, Arvin B, Zulkiflee AB, Prepageran N

Otolaryngol Head Neck Surg, 2018 10;159(4):783-788.
PMID: 30126325 DOI: 10.1177/0194599818795852

Objective To objectively compare the nasal decongestion potency of lidocaine/phenylephrine when delivered with a nasal nebulizer and a nasal spray before a rigid nasoendoscopic examination. Study Design Open-label randomized controlled trial. Setting Multicenter study. Methods This prospective clinical trial involved 106 participants with untreated chronic rhinitis. Fifty-three participants had 400 μL of lidocaine/phenylephrine administered into the right nostril with a nasal nebulizer, while the remaining 53 participants had 400 μL administered with a nasal spray. The control was the left nostril. Nasal resistance at 150-Pa fixed pressure was evaluated with an active anterior rhinomanometry at 5, 10, 15, and 30 minutes postintervention. Pain score was assessed subjectively by applying pressure to the inferior turbinate 30 minutes after intervention. Results There was an overall reduction in nasal resistance of the right nostril when lidocaine/phenylephrine was administered with the nasal nebulizer in comparison with the nasal spray. However, a statistically significant difference in nasal resistance was seen only at 5 minutes ( P = .047), 15 minutes ( P = .016), and 30 minutes ( P = .036). The examining endoscopist further supported the degree of nasal decongestion via subjective assessment of the nasal cavity ( P = .001). Pain scores obtained after the intervention showed a significant decrease in pain threshold when the nasal nebulizer was used instead of the nasal spray ( P = .040). Conclusions This study suggests that the delivery of lidocaine/phenylephrine to the nasal cavity by the nasal nebulizer provides better decongestive and analgesic potency as compared with the delivery by nasal sprays.

Matched MeSH terms: Nasal Sprays*
Fulltext Mometasone furoate intranasal spray is effective in reducing symptoms and adenoid size in children and adolescents with adenoid hypertrophy

Ghafar MHA, Mohamed H, Mohammad NMY, Mohammad ZW, Madiadipoera T, Wang Y, et al.

Acta Otorrinolaringol Esp (Engl Ed), 2019 08 07;71(3):147-153.
PMID: 31400807 DOI: 10.1016/j.otorri.2019.04.004

INTRODUCTION: The use of mometasone furoate (MF) intranasal spray in treating adenoid hypertrophy (AH) has a variable outcome due the different methods of adenoid size evaluation. The aim of our study was to evaluate the effect of MF intranasal spray in children and adolescents with AH using a reliable and consistent endoscopic evaluation.
MATERIAL AND METHOD: A prospective interventional study was conducted. Evaluation took place during the first visit (week 0) and second visit (week 12). Symptoms of nasal obstruction, rhinorrhoea, cough and snoring were assessed, and an overall total symptoms score was obtained. A rigid nasoendoscopic examination using a four-grading system of adenoid size from 1 to 4 was performed. Patients were treated with MF intranasal spray for 12 weeks. Patients' aged 7-11-years old used 1 spray in each nostril once daily, while patients aged 12-17 used two sprays in each nostril once daily. Reassessment was carried out during the second visit (week 12).
RESULTS: A total of 74 patients was recruited. There were significant improvements from week 0 to week 12 in the symptoms' score for nose obstruction, rhinorrhoea, cough, snoring including the total nasal symptoms' score (p<0.001). AH significantly reduced in size from week 0 (2.89±.87) to week 12 (1.88±.83) (p<0.001).
CONCLUSION: MF intranasal spray is effective in improving the symptoms attributed to AH as well as reducing the adenoid size. MF intranasal spray is advocated as a treatment option before adenoidectomy is considered.

Matched MeSH terms: Nasal Sprays
Fulltext Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression: Assessment of Long-Term Safety in a Phase 3, Open-Label Study (SUSTAIN-2)

Wajs E, Aluisio L, Holder R, Daly EJ, Lane R, Lim P, et al.

J Clin Psychiatry, 2020 04 28;81(3).
PMID: 32316080 DOI: 10.4088/JCP.19m12891

OBJECTIVE: To evaluate long-term safety and efficacy of esketamine nasal spray plus a new oral antidepressant (OAD) in patients with treatment-resistant depression (TRD).
METHODS: This phase 3, open-label, multicenter, long-term (up to 1 year) study was conducted between October 2015 and October 2017. Patients (≥ 18 years) with TRD (DSM-5 diagnosis of major depressive disorder and nonresponse to ≥ 2 OAD treatments) were enrolled directly or transferred from a short-term study (patients aged ≥ 65 years). Esketamine nasal spray (28-mg, 56-mg, or 84-mg) plus new OAD was administered twice a week in a 4-week induction (IND) phase and weekly or every-other-week for patients who were responders and entered a 48-week optimization/maintenance (OP/MAINT) phase.
RESULTS: Of 802 enrolled patients, 86.2% were direct-entry and 13.8% were transferred-entry; 580 (74.5%) of 779 patients who entered the IND phase completed the phase, and 150 (24.9%) of 603 who entered the OP/MAINT phase completed the phase. Common treatment-emergent adverse events (TEAEs) were dizziness (32.9%), dissociation (27.6%), nausea (25.1%), and headache (24.9%). Seventy-six patients (9.5%) discontinued esketamine due to TEAEs. Fifty-five patients (6.9%) experienced serious TEAEs. Most TEAEs occurred on dosing days, were mild or moderate in severity, and resolved on the same day. Two deaths were reported; neither was considered related to esketamine. Cognitive performance generally either improved or remained stable postbaseline. There was no case of interstitial cystitis or respiratory depression. Treatment-emergent dissociative symptoms were transient and generally resolved within 1.5 hours postdose. Montgomery-Åsberg Depression Rating Scale total score decreased during the IND phase, and this reduction persisted during the OP/MAINT phase (mean [SD] change from baseline of respective phase to endpoint: IND, -16.4 [8.76]; OP/MAINT, 0.3 [8.12]).
CONCLUSIONS: Long-term esketamine nasal spray plus new OAD therapy had a manageable safety profile, and improvements in depression appeared to be sustained in patients with TRD.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02497287.

Matched MeSH terms: Nasal Sprays