WAYNE, Pa., Oct. 13, 2016 /PRNewswire/ -- Egalet
Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty
pharmaceutical company focused on developing, manufacturing and
commercializing innovative treatments for pain and other
conditions, today announced that the U.S. Food and Drug
Administration (FDA) will not meet the previously announced
October 14 prescription drug user fee
act (PDUFA) date for ARYMO™ ER (morphine sulfate).
"Today we were informed that the FDA has identified no
particular issue with our application for ARYMO ER and that the
Agency is working on the product label," said Bob Radie, president and chief executive
officer. ""The FDA indicated that they need more time as they have
done with other abuse-deterrent opioid NDAs, and confirmed that no
additional scientific information or data is needed for our
application. We will continue to work closely with the FDA to bring
this important product to those living with chronic pain and the
healthcare professionals who treat them."
On August 4, 2016 an FDA Advisory
Committee voted 18 to 1 for approval of ARYMO ER and the Committee
recommended ARYMO ER should be labeled as an abuse-deterrent
product by the intravenous, nasal and oral routes of abuse. ARYMO
ER is being developed for the management of pain severe enough to
require daily, around-the-clock, long-term opioid treatment and for
which alternative treatment options are inadequate. If approved,
ARYMO ER would be the first product developed using Egalet's
proprietary Guardian™ Technology—a physical and chemical barrier
approach to abuse-deterrence that results in tablets that are
difficult to manipulate for the purpose of misuse and
abuse.
About Egalet
Egalet, a fully integrated specialty
pharmaceutical company, is focused on developing, manufacturing and
commercializing innovative treatments for pain and other
conditions. Egalet has two approved products: OXAYDO®
(oxycodone HCI, USP) tablets for oral use only –CII and
SPRIX® (ketorolac tromethamine) Nasal Spray. In
addition, using its proprietary Guardian™ Technology, Egalet is
developing a pipeline of clinical-stage, product candidates that
are specifically designed to deter abuse by physical and chemical
manipulation. The lead programs, ARYMO™ ER, an
abuse-deterrent, extended-release, oral morphine formulation, and
Egalet-002, an abuse-deterrent, extended-release, oral oxycodone
formulation, are being developed for the management of pain severe
enough to require daily, around-the-clock, long-term opioid
treatment and for which alternative treatment options are
inadequate. Egalet's Guardian Technology can be applied broadly
across different classes of pharmaceutical products and can be used
to develop combination products that include multiple active
pharmaceutical ingredients with similar or different release
profiles. For additional information on Egalet, please visit
egalet.com. For full prescribing information on SPRIX, including
the boxed warning, please visit sprix.com. For full prescribing
information on OXAYDO, please visit oxaydo.com.
Guardian™ Technology
Egalet's Guardian Technology has
many applications and has been used to develop commonly abused
prescription medications in an abuse-deterrent form. Egalet's
proprietary Guardian Technology is a polymer matrix tablet
technology that utilizes a novel application of the well
characterized manufacturing process of injection molding, which
results in tablets with controlled-release properties as well as
physical and chemical features that have been demonstrated to
resist both common and rigorous methods of manipulation. Guardian
Technology results in tablets that are extremely hard, very
difficult to chew, resistant to particle size reduction, and
inhibit/block attempts at chemical extraction of the active
pharmaceutical ingredient. In addition, the technology results in a
viscous hydrogel on contact with liquid, making syringeability very
difficult. These features are important to address the risk of
accidental misuse (e.g., chewing) in patients with chronic pain, as
well as intentional abuse using more rigorous methods of
manipulation.
Safe Harbor
Statements included in this press release
(including but not limited to anticipated labeling for ARYMO ER)
that are not historical in nature are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements are based on management's
current expectations, and are subject to known and unknown
uncertainties and risks. Actual results could differ materially
from those discussed due to a number of factors, including, but not
limited to: the success of Egalet's clinical trials, including the
timely recruitment of trial subjects and meeting the timelines
therefor; Egalet's ability to obtain regulatory approval of its
product candidates; Egalet's ability to maintain the intellectual
property position of its products and product candidates; Egalet's
ability to identify and reliance upon qualified third parties to
manufacture its products; Egalet's ability to service its debt
obligations; Egalet's ability to raise additional funds related to
execute its business plan and growth strategy in terms acceptable
to Egalet, if at all; Egalet's ability to find and hire qualified
sales professionals; the receptivity in the marketplace and among
physicians to Egalet's products; the success of products which
compete with Egalet's that are or become available; general market
conditions; and other risk factors described in Egalet's filings
with the United States Securities and Exchange Commission. Egalet
assumes no obligation to update or revise any
forward-looking-statements contained in this press release whether
as a result of new information or future events, except as may be
required by law.
Investor and Media Contact:
E. Blair Clark-Schoeb
Senior Vice President, Communications
Email: bcs@egalet.com
Tel: 917-432-9275
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SOURCE Egalet Corporation