CT001 launch under the Early Access program in the US is approaching 

Timing

Both teams have been very busy preparing for the launch under the Early Access Program in the US - and this includes both the new manufacturing setup outside New York and all the marketing activities supporting the launch. We anticipate within a few months that CT001 will reach the first hospitals.  

Key events 

Extensive planning and meetings have set the stage for a successful initial rollout, thus ensuring physicians understand the product, its profile and limitations and especially that patients have a positive experience. The first month is hence limited to selected states and hospitals before a wider distribution and promotion will take place. We will share more updates on the process after a few months on the market. 

Packaging and design

Ventis Pharma is almost done with the final packaging, the brand name and design and we are eager to share this once the final quality assurance has been completed, as the perception testing was completed last month. This will always be important for a launch, even if it is an Early Access Program, and it becomes very real once this is final and ready to be shipped. 

New patent application 

Cessatech strengthens its patent portfolio for CT001 to treat acute pain in children, with the publication of a new U.S. patent application (US20240100035A1) to reflects our ongoing commitment to building a strong intellectual property position around our intranasal CT001 combination product. We anticipate more news regarding the application during 2025.

Paediatric data to be published

Dental Study 0205 updates

In Dec 2023 we published the positive topline data in the important Dental study 0205 supporting further advancement of CT001. The demonstrated significant reduction in on a pain scale, and although superiority was not achieved for the sufentanil control arm in adults, the co-primary endpoint of preliminary modelled exposure-response data substantiates that CT001 is superior in children. The is an important statement and the team has been working hard to publish these data in children.

Modelling and simulations in Children

We anticipate this important unified PK-PD model, developed based on all available both adult and paediatric study data (0201, 0204, 0205, and 0206), which are modelling and simulating exposure-response is to be published at the end of Q2 this year. This will have significant importance to the company, the regulatory process and later commercialisation of CT001.