Aptar Pharma’s Bidose Nasal Drug Delivery Device Approved by U.S. FDA for Breakthrough Treatment of Depression
March 18 2019 - 5:00PM
Business Wire
Aptar Pharma, a leading drug delivery systems provider, is
pleased to announce that its Bidose nasal spray device was recently
approved by the U.S. FDA for a breakthrough therapy in the field of
depression. This marks the first FDA approval and U.S. launch of a
prescription drug using Aptar Pharma’s patented Bidose nasal spray
delivery system.
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Photo: Courtesy of Aptar Pharma
This approval again demonstrates Aptar Pharma’s expertise in
developing patient-friendly drug delivery solutions for
breakthrough medicines. Aptar Pharma offers a broad portfolio of
innovative technologies and wide array of services to meet the
highest quality standards of the pharmaceutical industry.
Ability to Build Long Term Collaborative Partnerships
Aptar Pharma’s key to success is its ability to build effective
partnerships with pharma customers to deploy complex projects
requiring rigorous methodology and joint governance. This
customized Bidose liquid device is produced in Aptar Pharma’s
state-of-the-art manufacturing facility in Congers, NY, which
offers laboratory and other organizational capabilities to support
nasal and injectable drug delivery systems.
Patented Bidose Technology Platform
Aptar Pharma’s Bidose liquid system is designed for local or
systemic delivery of drugs. As a robust, primeless, intuitive and
easy-to-use device with 360° functionality and precise spray
characteristics, the Bidose system provides accurate two-shot nasal
drug delivery.
The Aptar Pharma Bidose and Unidose systems offer biotech and
pharmaceutical companies effective and reliable intra-nasal
delivery platforms for a variety of medicines including potential
life-saving treatments and treatments of severe conditions.
This nasal product platform can enhance brand image via an
elegant and intuitive design while limiting the volume of drug
accessible to patients. The devices can also integrate wireless
connectivity technologies.
Accelerated Development Support via Aptar Pharma
Services
This breakthrough therapy approval is an example of a
Combination Product, and benefited from Aptar Pharma’s Services
offering, a comprehensive portfolio of stage-specific packages
designed to proactively address regulatory needs to accelerate
approval.
Leveraging its extensive value-adding capabilities including lab
and analytical services, proven regulatory expertise - with
dedicated Regulatory Affairs experts and fast approval data
packages - and customized drug delivery solutions, Aptar Pharma’s
Services can enable an expedited approval and launch in the
competitive pharmaceutical space.
“We are pleased that Aptar Pharma’s Bidose nasal delivery device
has been approved by the FDA for this breakthrough therapy in the
field of depression,” explained Gael Touya, President, Aptar
Pharma. “This project marks close to a 10-year customer
collaboration and once again demonstrates Aptar Pharma’s ability to
develop and launch complex drug delivery systems worldwide.”
About Aptar Pharma
Aptar Pharma is part of AptarGroup, Inc. (NYSE: ATR), a leading
global supplier of a broad range of innovative dispensing, sealing
and active packaging solutions for the beauty, personal care, home
care, prescription drug, consumer health care, injectables, food
and beverage markets. Aptar uses insights, design, engineering and
science to create innovative packaging technologies that build
brand value for its customers, and, in turn, make a meaningful
difference in the lives, looks, health and homes of people around
the world. Aptar is headquartered in Crystal Lake, Illinois and has
over 14,000 dedicated employees in 18 different countries. For more
information, visit www.aptar.com/pharma.
This press release contains forward-looking statements. Words
such as “future” and other similar expressions or future or
conditional verbs such as “will” are intended to identify such
forward-looking statements. Forward-looking statements are made
pursuant to the safe harbor provisions of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934 and are based on our beliefs as well as assumptions
made by and information currently available to us. Accordingly, our
actual results may differ materially from those expressed or
implied in such forward-looking statements due to known or unknown
risks and uncertainties that exist in our operations and business
environment. Additionally, forward-looking statements include
statements that do not relate solely to historical facts, such as
statements which identify uncertainties or trends, discuss the
possible future effects of current known trends or uncertainties or
which indicate that the future effects of known trends or
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additional information on these and other risks and uncertainties,
please see our filings with the Securities and Exchange Commission,
including the discussion under “Risk Factors” and “Management’s
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result of new information, future events or otherwise.
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Investor Relations
Contact:Matt
DellaMariamatt.dellamaria@aptar.com815-477-0424Media Contact:Carolyn
Penotcarolyn.penot@aptar.com+33 1 39 17 20 38
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