SPRAVATO® clears the path for depression treatment with FDA monotherapy approval
Published: 12 February 2025
Johnson & Johnson’s SPRAVATO® (esketamine) nasal spray has achieved a significant milestone, gaining approval from the Food and Drug Administration (FDA) as a monotherapy. This treatment is now the first and only monotherapy specifically for adults living with major depressive disorder (MDD) who have experienced inadequate responses to at least two oral antidepressants.
Shore and SPRAVATO®
At Shore, we’re proud to have collaborated with Johnson & Johnson Innovative Medicine (formerly Janssen during the project) to customise the nasal delivery platform for SPRAVATO®. Recognising the need for a tailored solution, the J&J project team identified us as the ideal partner to lead the customisation of the baseline device to meet the user group’s needs and J&J’s commercial launch objectives.
Our innovative approach boosted the nasal device’s usability without compromising the core functional elements of the platform technology.
SPRAVATO® trainer
To support the launch, we also developed a robust and repeatable trainer. We identified the key aspects of the delivery experience and built them into a reusable training device, giving patients the opportunity to become familiar and confident with the administration process before using the real device for the first time.
Having already supported the engineering development of the drug delivery device; we had an intimate knowledge of the device requirements and the needs of the intended user group. This helped us transfer the essence of the real device use into a teachable training experience that allowed the patient to become comfortable and ready to self-administer the real therapy.
We also understood the requirements of Janssens supply chain and regulatory processes, allowing us to manage the entire process which simplified the supply of the devices to multiple locations.
Further information
With SPRAVATO® now FDA approved as a monotherapy, its potential to transform the mental health landscape continues to grow. This approval marks a crucial step in addressing treatment-resistant depression, offering hope to patients and healthcare providers alike.
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For further insight into how we support medical and pharmaceutical companies with platform customisation and beyond, see our work page. Or contact our Business Development Manager, Holly Milston.
