AQS1302

AQS1302 is designed to be a once-daily, and up to a once-weekly transdermal form of clobazam.

Clobazam is a unique antiepileptic drug (AED) associated with fewer sedative side effects than other agents in its class. It is currently marketed worldwide (ex-US) for the treatment of epilepsy, anxiety and alcohol withdrawal under the brand name Frisium®. It was approved in the United States in 2013 for Lennox-Gastaut Syndrome (LGS) under the brand name Onfi®. Clobazam is currently available as an oral tablet, dosed twice daily, and can be challenging for a caregiver or parent to administer, particularly in patients with severe, debilitating epilepsies such as LGS where difficulty swallowing is common.. A long-acting form of clobazam in a non-invasive and easy to use patch is being developed to relieve this burden on patients and caregivers.

Aequus has engaged with over 50 specialized epileptologists and neurologists to understand the medical need for this product offering. The main findings from the market research to date have been:

    • Clobazam is used broadly across seizure types in territories outside of the United States
    • Medication adherence is a very important concern for prescribers; many expect an increase in seizure frequency or severity in patients missing a single dose of clobazam therapy; and
    • Many patients with LGS have dysphagia (difficulty swallowing) or feeding tubes, transdermal delivery would provide a needed alternative to oral AEDs

Market Need


Epilepsy

Epilepsy is a disorder which causes seizures: sudden surges of electrical activity in the brain which can cause impaired or lost consciousness and/or a loss or increase in muscle tone – depending on the type of seizure. Seizure onset occurs most frequently in childhood and older-adulthood. Epilepsies and epilepsy disorders range in severity; the impact the seizures have on individuals and their families can be very severe with concerns about having a seizure while swimming, driving, or in other potentially dangerous situations. Epilepsy has a prevalence of ~0.6%, affecting an estimated 1.9 million people in the United States.


LENNOX GASTAUT SYNDROME

Lennox Gastaut Syndrome is a rare, severe form of epilepsy characterized by frequent and multiple refractory seizures, on average seven per day. LGS is usually before the age of 8, most commonly between the ages of 3 and 5. The majority of LGS patients (91%) have some mental retardation and ~22% require a feeding tube or have difficulty swallowing (dysphagia). LGS accounts for 2-5% of childhood epilepsies.  -  (read more about Epilepsy & LGS...)