AZ-002 (Staccato alprazolam)
Epilepsy is a condition that causes seizures and is the fourth most common neurological problem in the world according to the Epilepsy Foundation. Approximately three million patients in the United States are living with epilepsy, and one-third of those patients have uncontrolled seizures because no available treatment works for them. Twenty percent of those patients have a seizure pattern that they can predict and are in need of a rescue treatment to stop on-going seizure activity before their seizure progresses. Currently, there are no approved products or products in development that can rapidly stop an active seizure in the outpatient setting.
Safety is a chief concern for patients with epilepsy who experience prolonged or on-going seizure activity. Prolonged or recurrent seizure activity may result in serious injury, health impacts or death, that correlates directly with seizure duration. Stopping seizure activity early before it has the opportunity to progress may allow patients to continue on with their normal activities and help prevent neurological damage.
Benzodiazepines are considered to be medications of first choice for the treatment of acute seizures. Clinical advantages of benzodiazepines include relatively rapid onset of action, high efficacy and minimal toxicity. The rapidity by which a medication can be delivered to the systemic circulation and then to the brain plays a significant role in reducing the time needed to treat seizures and reducing the likelihood of damage to the central nervous system.
The potential benefits of the Staccato system include a fast delivery to the blood stream, comparable to IV administration and ease of use in the outpatient setting. Staccato alprazolam could be administered immediately after seizure activity is recognized.
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