Amarin Corporation plc said it successfully completed a preclinical proof of concept study using a novel nasal formulation of lorazepam. The preclinical study evaluated the extent of absorption of lorazepam after nasal administration and the pharmacokinetics of the novel formulation. Amarin is now working with a subsidiary of Elan Corporation, plc to prepare this nasal formulation for human pharmacokinetic trials.
This nasal lorazepam formulation utilizes Elan's proprietary NanoCrystal Technology and is in development for the out-patient treatment of emergency seizures in epilepsy patients, specifically status epilepticus and acute repetitive seizures.
A seizure emergency is a prolonged seizure or continuous state of frequently occurring seizures. One common type of seizure emergency is called status epilepticus (SE). SE may be defined as a prolonged seizure lasting longer than 10 minutes. SE is also defined by a series of repeated seizures without the return of consciousness between seizures. SE has an annual incidence estimated at approximately 150,000 cases in the United States alone with approximately 40,000 deaths per year.
Another type of seizure emergency is acute repetitive seizures (ARS), which is a bout or cluster of seizures over a short period of time in which the patient regains consciousness between seizures. It is estimated that up to 400,000 people in the United States suffer from ARS.
Epilepsy is a very common disorder affecting approximately 0.5% of the population and is characterized by seizures, which may vary from the briefest lapses of attention to muscle jerks to severe and prolonged convulsions. They may also vary in frequency, from less than one a year to several per day.
Amarin is committed to improving the lives of patients suffering from central nervous system and cardiovascular diseases. The company's goal is to be a leader in the research, development and commercialisation of novel drugs that address unmet patient needs.