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Psychedelics

Spravato Wins Breakthrough New Approval From FDA

January 21, 2025
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Spravato depression treatment
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The future of psychedelic derived medicines just got even more promising.

What’s happening:

  • Johnson & Johnson (NYSE: JNJ) has officially received approval from the United States Food and Drug Administration for Spravato to be used as a monotherapy for individuals with treatment resistant depression

Why it matters:

  • Spravato had already been previously approved by the United States Food and Drug Administration for use in combination with an oral antidepressant, however this new approval represents the first time Spravato has been cleared to be used as a stand alone therapy to treat individuals with treatment resistant depression

By the numbers:

  • The newest approval from the United States Food and Drug Administration came after a recent clinical trial in which individuals who took Spravato saw an improvement in their depressive symptoms within 24 hours
  • Spravato’s latest clinical trial also successfully validated that the drug achieved all of their primary endpoints within 4 weeks

Going deeper:

  • Spravato is a nasal spray which is derived from ketamine and has been widely seen as validation for the future of psychedelic medicines to change the paradigm of mental health treatments

The intrigue:

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