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December 10, 2019

FDA approves Aptar’s acute repetitive seizures treatment device

The US Food and Drug Administration (FDA) has approved Aptar Group’s Unidose Liquid System to treat acute repetitive seizures in those with epilepsy.

The US Food and Drug Administration (FDA) has approved Aptar Group’s Unidose Liquid System to treat acute repetitive seizures in those with epilepsy.

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Claimed to be the first and only nasal rescue treatment for seizures, Aptar’s Unidose Liquid System is a single-use, ready-to-use one-step nasal delivery device that can deliver a formulation in an emergency.

Non-healthcare professionals can administer the nasal delivery device to a patient during or after a seizure.

When the patient or caregiver presses the small plunger on the bottom of the device, the drug is released in a single spray into the nostril, where the nasal mucosa quickly absorbs it.

Recently, Aptar acquired Noble International, which developed a trainer device for use as part of a patient onboarding programme for the new device.

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 a wide array of services to meet the highest quality standards of the pharmaceutical industry.”

Aptar Pharma president Gael Touya said: “The launch of our Unidose System on the first and only USFDA approved nasal rescue treatment for seizure activity once again demonstrates Aptar Pharma’s ability to help our customers develop and launch complex treatments.

“When we combine our nasal systems’ capabilities with Noble’s training devices for onboarding, we bring added value to our customers and further convenience for patients and consumers worldwide.”

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Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
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