According to Cessatech, a positive notified body opinion has been issued under Article 117 of the Medical Devices Regulation for the company’s CT001 sufentanil / ketamine nasal spray. Cessatech says that it expects to submit a marketing application to the EMA later this year seeking approval of CT001 for the treatment of acute pain in children.
In May 2024, the company announced the initiation of a pediatric Phase 3 trial of CT001; that trial is still underway. Later that year, UK-based pediatric pharmaceuticals company Proveca acquired global rights to the intranasal sufentanil / ketamine.
Cessatech Chief Scientific Officer Martin Juhl commented, “We are very proud to have received this positive opinion from the notified body. It is a testament to the team’s dedication to scientific rigor and quality in meeting MDR requirements. We are pleased that the quality of our technical documentation and approach has been recognized through this positive opinion.”
CEO Jes Trygved said, “The MDR assessment is a major achievement for the company and is an integrated part of the EMA approval process of CT001. We are now one important step closer to getting CT001 approved in Europe for children aged 1-17 years old, together with our commercial partner Proveca. . . . It is an amazing effort that we completed our assessment within the estimated timeframe. Thanks to all for an amazing effort.”
Read the Cessatech press release
