What types of seizures does it work for?
How does this device work if a person can’t administer during a seizure?
There already exist rescue products on the market. What is so special about this one?
What are the side effects?
Is there a risk of overdose?
How often can I use this product in real life?
Is there risk of addiction?
How much will it cost?
Is there a trial site in my city?
My question isn’t listed. Can you help?
The Staccato system is a small, portable device that consists of three components: a heating substrate, a thin film of the drug coated on the substrate, and an airway through which the patient inhales alprazolam, a short-acting benzodiazepine.
This product is designed for patients with focal or generalized epilepsy who experience aura (prodrome) or warning signs with the onset of a seizure, or who have a predictable evolution of their seizures that can be stopped with this type of fast-acting treatment. Because a caregiver can administer the product, we anticipate that anyone with seizures could utilize the product.
Some patients will be able to self-administer this product as a seizure is evolving. For those who cannot, it would be necessary for a caregiver to administer. This involves removing the device from packaging and placing the device to the patient’s mouth. There is no need to purposefully inhale; the Staccato system rapidly vaporizes the drug to form a small particle aerosol, which is drawn through the patient’s mouth and into the lungs. Here, it diffuses into circulation where it is designed to have a rapid systemic effect.
While there are other types of epileptic seizure rescue therapies on the market, there are no FDA-approved options as fast-acting as Staccato Alprazolam. In a phase 2a study, Staccato Alprazolam demonstrated a reduction in seizure-like activity in two minutes. Also, the administration of this product is non-invasive, making it more practical for use in public. Other rescue products on the market are indicated for ARS (acute Repetitive seizures) and are intended to prevent the next seizure in a cluster. However, our goal is to show that this product will stop a seizure in evolution, and so it will be indicated for a broader class that we call REST (Rapid Epilepsy Seizure Termination) based on the faster onset of action.
Some trial patients have reported drowsiness and a bad taste in the mouth, but there have been no reports of any major adverse events with this product.
This product delivers a metered single dose, which prevents repetitive use.
The frequency of use will be determined by the FDA once this product is approved.
Alprazolam is a benzodiazepine, a class of drugs that is associated with risk of dependency. However, this device will not be indicated for daily use. The FDA will determine how often Staccato Alprazolam may safely be administered.
It is impossible to predict the cost of this device, as pricing depends on future market variables. However, Engage Therapeutics is committed to making this product readily available for those who need it. Toward this end, if we see this product to market, we will work to ensure coverage of this device for Medicare, Medicaid, and privately insured patients, and we will explore the possibility of rebates and discounts to reduce out of pocket costs not covered by insurance.
There will be more than 50 U.S. trial sites for the StATES study with additional locations being added weekly. Trial participants are eligible for compensation for costs incurred to travel to their closest study location. For a map of current locations, visit https://engagetherapeutics.com/study-locations/.