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Janssen’s Spravato Enters US Market With Enhanced REMS And Plans For A Monotherapy Trial

 
• By Sue Sutter

Restrictive risk management plan for antidepressant nasal spray requires patients be monitored for two hours after dosing and enroll in a patient registry; Janssen has agreed to conduct a monotherapy efficacy trial as a postmarketing commitment.

Spravato manufacturing
Janssen is manufacturing Spravato in anticipation of a US roll-out starting in mid-March. • Source: Janssen

The US FDA approved Janssen R&D LLC’s antidepressant Spravato (esketamine) March 5 with an enhanced Risk Evaluation and Mitigation Strategy (REMS) but also a postmarketing commitment for a monotherapy study that the agency itself has suggested would be difficult to conduct.

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