FDA approves Aptars Unidose device to treat acute repetitive seizures
AptarGroup has secured approval from the US Food and Drug Administration (FDA) for its Unidose Liquid System as a nasal rescue treatment for frequent seizure activity.
The Unidose device has been designed to treat acute repetitive seizures in people living with epilepsy.
Aptar’s recently-acquired Noble International designed a trainer device in collaboration with the customer to be used as part of a patient onboarding programme for the new drug product.
Unidose is a single-use and ready-to-use one-step nasal delivery device
Unidose is a ready-to-use one-step nasal delivery device developed to quickly provide a formulation in an emergency situation. It can be administered by a non-healthcare professional to a patient during or after a seizure.
During a seizure event, the patient or caregiver has to press a small plunger on the bottom of the device to release the drug in a single spray into the nostril. The process helps to quickly absorb the drug through the nasal mucosa.
Aptar’s Unidose and Bidose platforms are said to be primeless and advanced systems with 360° functionality and accurate nasal drug delivery.
Biotech and pharmaceutical companies can use the both platforms for single or two-shot intranasal delivery of different medicines including potential life-saving drugs and treatments of severe conditions. In addition, the device can incorporate wireless connectivity technologies.
Aptar president and CEO Stephan Tanda said: “This approval and successful market launch further demonstrate the broad potential for Aptar’s patient-friendly drug delivery solutions and service offerings which help our pharmaceutical customers address unmet healthcare needs.
“We are pleased to offer a broad portfolio of innovative technologies and wide array of services to meet the highest quality standards of the pharmaceutical industry.”
In July this year, AptarGroup secured FDA approval for its Unidose Powder System. It was approved for an intranasal and needle-free rescue treatment drug to treat severe hypoglycemia in people with diabetes.