What you need to know about Spravato


August 6, 2020

There is no shortage of news articles outlining the increase in depression and anxiety across the US with the COVID pandemic and social distancing guidelines. Even before the pandemic, America has been in the throes of a suicide crisis, with the suicide rate consistently rising over the last two decades.[1] There have been limited pharmaceutical innovations to treat depression since the initial release of Prozac in the late 1980s.

Recently, Spravato®, a nasal spray used to treat depression that was originally approved in March 2019 is again making headlines across the mental health field. The information below provides a quick overview about this drug and how it can affect your plan and your members.

What is Spravato and why is it back in the news?

  • Spravato (esketamine) CIII nasal spray is the first and only approved medicine to reduce depressive symptoms within 24 hours[2] – with some patients starting to respond in as little as four hours.[3]   
  • It is taken in addition to oral antidepressants to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.
  • Spravato has been used by about 6,000 people for treatment-resistant depression since its approval in 2019.[4]  Over 2M American adults suffer with MDD.
  • On August 3, 2020, the Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for Spravato as the first antidepressant for actively or acutely suicidal people.

A new, but controversial, FDA approval

  • Spravato is a close chemical cousin of the anesthetic, ketamine. Ketamine has not been approved by the FDA to treat depression.
  • Doctors and clinics across the country have been using off-label IV ketamine treatments for years and claim that it works rapidly and robustly. However, this off-label use remains highly controversial across the mental health provider community.
  • Spravato’s approval now creates the perception that the FDA condones ketamine treatment as appropriate for treatment of depression.
  • The sNDA approval is based on two identical Phase 3 clinical trials. However, since Spravato is used in conjunction with an oral antidepressant, some physicians believe it is difficult to know the true trial results that led to the initial March 2019 FDA approval.
  • Spravato comes with high risk of serious side effects – sedation/loss of consciousness, dissociation, high blood pressure, arrhythmia, hallucinations and chemical abuse/dependence.

 

What does this mean for your plan and members?

Reach out for recommendations from our experts.

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[1] https://medicalxpress.com/news/2020-08-nasal-suicidal-people.html

[2] https://www.prnewswire.com/news-releases/janssen-announces-us-fda-approval-of-spravato-esketamine-ciii-nasal-spray-to-treat-depressive-symptoms-in-adults-with-major-depressive-disorder-with-acute-suicidal-ideation-or-behavior-301104437.html

[3] https://www.thepharmaletter.com/in-brief/brief-fda-approves-new-use-for-spravato

[4] https://theprint.in/health/us-fda-approves-jjs-quick-acting-nasal-spray-to-treat-suicidal-people/474022/