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