Aptar Pharma’s Electronic Lockout Device Approved by EMA
May 15 2017 - 8:00AM
Business Wire
Aptar Pharma, a world leader in innovative drug delivery
systems, is pleased to announce the approval by the European
Medicines Agency (EMA) of the first integrated electronic nasal
lockout device (e-Lockout) following a multi-year development with
Takeda Pharmaceuticals International AG. Aptar Pharma agreed to
supply Takeda with its e-Lockout device for a multidose nasal spray
version of Instanyl®. The EMA has granted marketing authorization
for this multidose nasal spray treatment under the name Instanyl
DoseGuardTM.
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Courtesy of Aptar Pharma
This represents a major milestone for Aptar Pharma, with the
e-Lockout device being the first and only fully integrated
electronic nasal drug delivery device to be approved by a U.S. or
European regulatory authority.
Already available in unidose and multidose nasal spray versions,
Takeda will launch Instanyl® DoseGuard in Europe in several
multidose strengths, all using Aptar Pharma’s patented electronic
lockout system, which marks another product innovation in the
management of breakthrough pain.
Advanced e-Device Technology Ensures Safe Compliance
Instanyl® is a fast-acting nasal opioid approved for relieving
breakthrough pain in adult cancer patients already treated with
opioids for their usual pain. Breakthrough pain is an additional
sudden pain that occurs despite having taken one’s usual pain
relieving medicines.
Aptar Phama’s e-Lockout device uses advanced electronic
technology to help patient compliance in the treatment of chronic
disease. Aptar Pharma’s e-Lockout device is intended to ensure safe
patient compliance by limiting the number of doses available during
a 24 hour period.
The system’s built-in lock-out mechanism prevents the device
from being used for a period of time after a pre-defined number of
spray actuations. The electronic display shows the number of
priming strokes, the number of doses left in the device and whether
the nasal spray is locked or ready for use. The e-Lockout also
features a child-resistant cap.
Long-term Strategic Partnership with Takeda
The multi-year supply agreement reinforces a long-standing
partnership between Takeda and Aptar Pharma, who currently supplies
Takeda with unidose and multidose nasal spray devices for Instanyl®
in Europe.
Committed to accompanying pharmaceutical companies throughout
their product lifecycle management, Aptar Pharma continues to
partner to provide customers with innovative and smart solutions to
enable safe, convenient and compliant medication delivery.
“This approval and subsequent product launch underscores Aptar
Pharma’s ability to partner with the pharma industry to bring
innovative, compliant and safer devices through the regulatory
authorization process,” explained Salim Haffar, President, Aptar
Pharma. “This is yet another example of Aptar Pharma’s expertise
and technology at the heart of a new market launch. This is a
significant step in strengthening Aptar Pharma’s credentials in the
electronics and connected health markets. We are pleased to be
building on our trusted, long-term partnership with Takeda,” he
added.
About Aptar Pharma
Aptar Pharma is part of AptarGroup, Inc. (NYSE: ATR), a leading
global supplier of a broad range of innovative dispensing and
sealing solutions for the beauty, personal care, home care,
prescription drug, consumer health care, injectables, food and
beverage markets. AptarGroup is headquartered in Crystal Lake,
Illinois, with manufacturing facilities in North America, Europe,
Asia and South America. For more information, visit
aptar.com/pharma.
This press release contains forward-looking statements. Words
such as “expects,” “anticipates,” “believes,” “estimates,” “future”
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made pursuant to the safe harbor provisions of Section 27A of the
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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
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please see our filings with the Securities and Exchange Commission,
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Media Contact:Carolyn
PenotAptar Pharma+33 1 39 17 20
38carolyn.penot@aptar.comorInvestor
Relations Contact:Matthew DellaMariaAptarGroup, Inc.+1
815 477 0424matt.dellamaria@aptar.com
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