To be able to obtain marketing authorisation for the indications conscious sedation and in acute epileptic seizure control, both in children and in adults, a data package need to be presented to the authorities. This package will encompass information on chemical & manufacturing control, non-clinical data (e.g. local tolerance on the nasal mucosa in animals) and clinical data (e.g. pharmacokinetic and pharmacodynamic data in humans). The European Medicine Agency has responded positively to the data package the company is generating to obtain marketing authorisation.
MEDIR recently has finalized the clinical data package, from which it is concluded that the product has the following characteristics:
- rapid absorption
- fast onset and predictive duration
- relative high bioavailability
- excellent nasal tolerance.
The formulation can be classified as very stable.