SUMMARY

• SPRAVATO is not indicated for use in cancer pain.
• In the phase 3 clinical programs for treatment-resistant depression (TRD) and major depressive disorder and active suicidal ideation (SI) with intent,^1-7 patients were excluded for a history of malignancy within 5 years before the start of the screening/prospective observational phase (exceptions were squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix or malignancy that, in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence).^8-13
• A case series described 3 patients in palliative care for cancer whose depression improved after initiating SPRAVATO for TRD with SI without intent.¹⁴ 

CLINICAL DATA

Tomy et al (2025)¹⁴ reported a case series of 3 patients with cancer who received treatment with SPRAVATO for TRD and SI without intent. The Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR-16) was used to assess depressive symptoms in all patients.

• Patient 1: A 52-year-old male patient with metastatic left gluteal muscle sarcoma received SPRAVATO for worsening depressive symptoms with recurrent SI without intent. The patient's psychiatric history included recurrent major depressive disorder (MDD), generalized anxiety disorder (GAD), and alcohol use disorder. Previously, he had been nonresponsive to sertraline and aripiprazole, and his current medications included duloxetine, risperidone, and trazodone. At ~2 weeks after initiating SPRAVATO, a marked improvement in QIDS-SR-16 score was reported with no suicidal thoughts. However, at 7 weeks, due to worsening depressive symptoms, the SPRAVATO dosage was increased to twice weekly for 4 weeks, followed by once weekly until the end of the treatment period of 56 weeks. Throughout his treatment, despite fluctuating symptoms, the patient's QIDS-SR-16 scores remained below the baseline. During SPRAVATO treatment, the patient experienced transient episodes of sedation, dissociation, and increased blood pressure; all events resolved without interventions. No withdrawal symptom was reported after SPRAVATO was discontinued.
• Patient 2: A 56-year-old male patient with stage 4 rectal carcinoma received SPRAVATO for severe depressive symptoms with daily SI without intent. The patient's psychiatric history included recurrent MDD, GAD, and post-traumatic stress disorder. Previously, he had been nonresponsive to aripiprazole and venlafaxine, and his current medications included duloxetine and nortriptyline. At ~2 weeks after initiating SPRAVATO, a significant improvement was reported in mood with resolution of SI. However, at ~24 weeks, due to worsening depressive symptoms precipitated by interpersonal stressors, the SPRAVATO dosage was increased to twice weekly for 4 weeks and then to SPRAVATO 84 mg once weekly until the end of the treatment period of 52 weeks. Overall, after receiving SPRAVATO, the patient experienced a marked improvement in his mood with no further SI. During SPRAVATO treatment, the patient experienced occasional episodes of sedation requiring no interventions; no other serious adverse events were reported.
• Patient 3: A 39-year-old female patient with recurrent mucinous ovarian cystadenoma received SPRAVATO for worsening depressive symptoms with intermittent SI without intent following her diagnosis. The patient's psychiatric history included recurrent MDD and GAD; she also experienced daily episodes of "panic attacks". Previously, she had experienced limited benefit to or was intolerant of aripiprazole, bupropion, citalopram, duloxetine, methylphenidate, mirtazapine, valproate, and venlafaxine; her current medications included olanzapine and nortriptyline. At ~2 weeks after initiating SPRAVATO, an overall improvement in mood was reported with no suicidal thoughts. The patient also reported less frequent "panic attacks" with faster resolutions. Clonazepam was initiated for the panic symptoms, and nortriptyline was discontinued due to side effects. While on SPRAVATO, the patient resumed work and continued treatment for ~32 weeks without dose adjustments. During SPRAVATO treatment, no serious adverse events were reported, and no withdrawal symptom was reported after SPRAVATO discontinuation.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 13 February 2025.