- The European Paediatric Committee (PDCO) has agreed to a 50% reduction in the number of children required in the final safety study (0202) of CT001 for the treatment of acute and procedural pain in children
- New safety data from both adult and paediatric studies has been presented to PDCO and based on this information, the PDCO agreed to the proposed reduction in number of children
- With this PDCO opinion, study 0202 will have a much shorter recruitment period and at less costs that previously anticipated. The study is now approved by the competent authorities in
Spain andUK
On 25 October -
CT001 is a nasal spray under development for treatment of acute and procedural pain in children. The development of CT001 in
"We have now completed 4 clinical studies with 375 patients being exposed to CT001 without any safety and tolerability concerns. The agreement from EMA's Paediatric Committee also acknowledges that we seem to have sufficient safety information and can reduce the number of required children for study 0202. We are of course delighted about this opportunity because it means that we will be closer to completing the development of CT001. We are excited to soon start the study activities at several clinical sites in
Jes Trygved, CEO,
We are very pleased with the acknowledgement from PDCO and that we can now initiate the study with a much lower number of children. A great effort by the team and the sites involved. With the agreement from EMA's Paediatric Committee, CT001 is now one step closer to finalize the clinical program and becoming available to hospitals and the children that really need approved, easy to administer pain relief."
For more information about
Jes Trygved, CEO
Phone: +45 9387 2309
E-mail: jes.trygved@cessatech.com
www.cessatech.com
About
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