Johnson and Johnson (NYSE: JNJ) on Wednesday reported that esketamine nasal spray Spravato showed superior efficacy compared to quetiapine extended-release (XR) in adults with major depressive disorder (TRD) in a 3b trial.
Quetiapine, among others, is marketed as Seroquel and previously marketed by AstraZeneca (NASDAQ: AZN) until the British pharmaceutical giant sold the rights to the drug to Luye Pharma for sure countries markets, and Cheplapharm of the US and the Canadian market.
Seroquel was widely used to treat schizophrenia and bipolar disorder and lost its patent protection worldwide.
The study, called ESCAPE-TRD, included 676 adults with TRD who received Spravato (n = 336) or quetiapine XR (n = 340), both in addition to continuing to choose a serotonin reuptake inhibitor (SSRI) or a serotonin and norepinephrine reuptake inhibitor. (SNRI).
The trial met its primary goal as more people on Spravato (27.1%) were in remission at week eight, compared to quetiapine XR (17.6%), Janssen Pharmaceutical of J&J said in a press release.
The study also met its second objective, showing that more participants on Spravato (21.7%), compared to quetiapine XR (14.1%) were in remission at week 8, and did not relapse until week 32, the company added.
Janssen reported that the remission rate continued to increase in both groups after the primary goal at week 8 with a higher proportion of patients in remission at week 32 in the Spravato group (55%), versus the quetiapine XR arm (37%).
“We are pleased to see that esketamine nasal spray has been shown to be effective and well-tolerated against a strong comparator in helping people achieve remission and relapse-free goals for up to 32 weeks – important and critical steps in the treatment of TRD,” said Tamara Werner-Kiechle, EMEA. Therapeutic Area lead, Neuroscience and Pulmonary Hypertension, Janssen-Cilag, a division of Janssen.
The company added that the most common adverse events (≥10%) observed in the Spravato group were dizziness (46.7%), nausea (29.3%), dissociation (28.1%), headache (24.6%) and vertigo (18.9%). ), among others. These results were consistent with safety data collected in previous studies, according to the company.
Janssen said serious TEAEs were seen in 5.1% of participants in the quetiapine XR arm and 5.7% in the Spravato group.
Meanwhile, 23.2% of people in the Spravato group stopped treatment, compared to 40.3% in the quetiapine XR arm, Janssen added.
Spravato, used in combination with an oral antidepressant, was approved in the US in March 2019 to help adults with treatment-resistant depression.