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 has been presented to the authorities. This package encompassed 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).
From the data package, it can be concluded that the product has the following characteristics:
- rapid absorption
- fast onset and predictive duration
- relative high bioavailability
- excellent nasal tolerance
- very stable.
In January 2022, the EMA recommended authorisation of Nasolam in the EU for acute epiletic seizure treatment and for conscious sedation/premedication, in children, adults and elderly.