Napatrin: clinical development of a novel nasal spray of sufentanil/ketamine for treatment of acute pain in children.

Acute pain related to medical interventions or diagnostic procedures, socalled procedural pain, is associated with a wide variety of hospital interventions such as venepunctures, insertion of peripheral intravenous catheters, removal of chest tubes, lumbar punctures, injections, burn dressings, and suturing of lacerations. Particularly for children, current treatment is either off-label use or insufficient, and is either intravenous (causing further pain), or not approved for younger children (less than 5 years old) or not even tested. Pain medication given orally or rectally have a slow onset of action. Hence, there is a huge, unmet need for an approved needle-free analgesic with a fast onset of action. In Europe alone, the annual market is estimated to over100 m€. Napatrin, developed by this consortium of three Scandinavian companies with complementary expertise, offers a solution to this major, unmet medical need. Napatrin is an innovative formulation allowing a low-dose combination of well-known medications, sufentanil and ketamine, to be administered as a nasal spray to children. This proposal contains essential elements of the paediatric investigational plan (PIP) that has been agreed with the European Medicines Agency (EMA) in order to obtain a paediatric-use marketing authorization (PUMA). Interim output include: (1) the successful manufacturing development of the novel nasal spray formulation of low-dose sufentanil and ketamine; (2) to conduct three pivotal clinical studies, two for characterising the pharmacokinetics (PK) in adults and children, respectively – and one dose-response and efficacy study in adults; (3) based on those studies, modelling and simulating to extrapolate efficacy to children; (4) to collate, analyse and present all documentation in a regulatory dossier for submitting to EMA through a centralized procedure to obtain the PUMA; and (5) to develop an early market access strategy through the use of an eCommerce platform.