Clinical Johnson & Johnson introduces nasal spray for depression

Johnson & Johnson introduces nasal spray for depression

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Johnson & Johnson (J&J) has introduced an esketamine nasal spray that can treat patients suffering from depression.

The company released its findings from their phase 3b ESCAPE-TRD study, which pitted its esketamine spray- Spravato, against extended-release quetiapine. AstraZeneca sold the extended-release quetiapine as Seroquel XR, before selling the rights to Cheplapharm in late 2019. Seroquel and Seroquel XR are medications that are used for the treatment of schizophrenia and bipolar disorder while esketamine is a treatment for depression.

As per a press update, in a study conducted on patients suffering from major depression for multiple months, J&J’s medication Spravato has achieved a better rating as compared to extended-release quetiapine on the Montgomery Depression Rating Scale. Spravato also achieved the critical secondary goal of assisting patients in remaining relapse-free for up to 32 weeks.

The study included 676 patients with treatment-resistant depression (TRD), 336 of whom were given Spravato, and 340 were given extended-release quetiapine. An option of continuous selective serotonin reuptake inhibitor or a serotonin and norepinephrine reuptake inhibitor was also provided to both groups.

Looking further into the findings, 27.1% of participants given Spravato had achieved remission after eight weeks, compared to 17.6% of quetiapine patients. Furthermore, remission rates for Spravato patients continued to rise beyond that point, with 55% in remission at 32 weeks compared to 37% in the comparison sample. On the trial’s secondary objective, 21.7% of Spravato patients remained relapse-free after 32 weeks, compared to 14.1% of quetiapine patients.

The FDA approved Spravato in 2019 based on phase 3 data that compared it to a placebo and an oral antidepressant. J&J promoted studies at the time demonstrating that patients with TRD in remission who continued to use Spravato were 51% less likely to relapse, when compared to those who maintained a placebo and an oral antidepressant regimen.

As per global reports, there is competition for J&J’s medication in the future with other fast-acting antidepressants, such as Axsome Therapeutics’ recently approved Auvelity, Sage Therapeutics medication zuranolone, Biogen Therapeutics methadone, and Seelos Therapeutics’ SLS-002, an intranasal formulation of racemic esketamine.

Professor Andreas Reif from the University Hospital in Frankfurt stated:

“Achieving remission and remaining relapse-free are major milestones in the treatment of depression and are especially challenging in TRD, where patients have not responded to previous therapies.”

The price of the medication is on the higher end, with public sources estimating the cost of two 28-mg Spravato dosages at roughly $730 before discounts. 

An appeals court concluded earlier this autumn that England’s National Institute for Health and Care Excellence may have made an error in its previous rejection of J&J’s Spravato for TRD. In a favorable indication for the introduction, the U.S. Department of Veterans Affairs said in 2019 that the medicine will be made available to veterans.

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