Patient Resources for
Status Epilepticus (SE)
Status epilepticus (SE) is an epileptic seizure of prolonged duration of more than five minutes or several seizures within a five-minute period where the individual does not recover between seizures. SE is a medical emergency associated with significant morbidity and mortality.
While there are no FDA approved treatments for SE, single or combinations of intravenous (IV) antiepileptic drugs (AEDs) are used to attempt to break the seizures. We are developing ganaxolone IV for the hospital setting, offering a new mechanism of action for SE patients who continue to experience seizures despite treatment, a clinical situation referred to as refractory status epilepticus (RSE).
How does Status Epilepticus affect the body?
Convulsive SE occurs when the active part of a tonic-clonic seizure lasts 5 minutes or longer, a person goes into a second seizure without recovering consciousness from the first one, and/or the person has repeated seizures for 30 minutes or longer. This type of status epilepticus requires emergency treatment by trained medical personnel in a hospital setting. Nonconvulsive SE describes long or repeated absence or focal impaired awareness (complex partial) seizures, in which symptoms can be more subtle. EEG testing may be needed to confirm the diagnosis of nonconvulsive SE first.
Where can I find more information on Status Epilepticus?
You can find additional educational and support resources on Status Epilepticus through the following foundations and patient advocacy groups:
Links to third party sites are provided for convenience purposes only. The information contained on these sites is not information provided, controlled or monitored by Marinus Pharmaceuticals in any way. Marinus Pharmaceuticals is not responsible in any way for the accuracy, completeness or fitness for any particular purpose of any content appearing on such sites.
Clinical Development of Ganaxolone in Status Epilepticus
Findings from the Phase 2 clinical study evaluating IV ganaxolone in 17 patients with RSE met the primary endpoint with no patients progressing to IV anesthetics within 24 hours of treatment initiation. Top-line efficacy data showed a median time to status cessation to be five minutes in 15 evaluable patients. Most patients showed positive trends in health outcomes such as the length of their hospital stay. The most commonly reported treatment-related adverse events were somnolence, mild hypotension and sedation. Overall, every dose regimenof IV ganaxolone had an acceptable safety and tolerability profile for the RSE patient population.
Patients received IV ganaxolone adjunctive to standard of care with currently available IV AEDs. IV ganaxolone was administered in three different dose cohorts with each consisting of a loading dose followed by continuous infusion for up to 96 hours, followed by a taper. RSE patients enrolled in the study failed a mean of 2.1 second line IV AED but did not progress to third line anesthetics.
Data from preclinical studies, conducted at two separate laboratories using different measurements, yielded positive results testing ganaxolone IV in benzodiazepine-resistant SE. Ganaxolone IV promoted survival and showed better or comparable reversal of seizures than the endogenous neurosteroid allopregnanolone, in clinically translatable rodent models of SE.
Ganaxolone IV has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of SE.