WAYNE, Pa., Nov. 28, 2017 /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 positive top-line results from a phase
3 study evaluating the efficacy and safety of Egalet-002, an
abuse-deterrent, extended-release oxycodone developed using a
unique application of the Guardian™ Technology. This second of two
Phase 3 studies was a multicenter, double-blind, enriched
enrollment, randomized withdrawal, efficacy and safety study of
Egalet-002 versus placebo in opioid-experienced and opioid-naïve
patients with moderate-to-severe chronic low back pain.
The study met its primary endpoint, which showed a statistically
significant difference in average pain intensity from baseline (at
randomization) to week 16 between the Egalet-002 and placebo
treatment groups (p<0.0001). In a previously announced Phase 3
safety study, Egalet-002 was generally well-tolerated and no new
safety concerns were identified in this study.
"These results demonstrate Egalet-002, an abuse-deterrent,
extended-release oxycodone, provided effective pain relief for
patients with moderate-to-severe chronic back pain," said
Bob Radie, president and chief
executive officer of Egalet. "Given the prevalence of chronic back
pain combined with the prescription abuse epidemic, we believe
development of more abuse-deterrent products like Egalet-002 is
important for our communities."
Guardian™ Technology
Egalet's Guardian Technology has many applications and has been
used to develop abuse-deterrent forms of commonly abused
prescription medications. 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 that are hard and
difficult to manipulate for misuse and abuse. This approach offers
the ability to design tablets with controlled-release profiles as
well as physical and chemical properties that have been
demonstrated to resist both common and rigorous methods of
manipulation. Tablets manufactured with Guardian Technology have
been shown to have increased resistance to physical methods of
manipulation, such as cutting, crushing, grinding or breaking,
using a variety of mechanical and electrical tools. They are also
resistant to chemical manipulation and attempts at extraction and
turn into a viscous hydrogel on contact with liquid, making
syringeability very difficult.
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 three approved products: ARYMO®
ER (morphine sulfate) extended-release tablets for oral use —CII,
developed using Egalet's proprietary Guardian™ Technology,
OXAYDO® (oxycodone HCI, USP) tablets for oral use only
—CII and SPRIX® (ketorolac tromethamine) Nasal Spray.
Using Guardian Technology, Egalet is developing a pipeline of
clinical-stage, product candidates for which we are seeking
partners including Egalet-002, an abuse-deterrent,
extended-release, oral oxycodone formulation 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. 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 full prescribing information on ARYMO ER, including
the boxed warning and medication guide, please visit arymoer.com.
For full prescribing information on SPRIX, including the boxed
warning and medication guide, please visit sprix.com. For full
prescribing information on OXAYDO, including the boxed warning and
medication guide, please visit oxaydo.com.
Safe Harbor
Statements included in this press release that are not historical
in nature and contain the words "anticipate," "believe,"
"estimate," "expect," "intend," "may," "plan," "predict,"
"project," "suggest," "target," "potential," "will," "would,"
"could," "should," "continue," "look forward to" and other similar
expressions 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
successful implementation and realization of the anticipated
benefits from Egalet's expense reduction plan; Egalet's estimates
with regard to its operating plan, expenses, future revenues,
capital requirements and needs for additional financing; the
success of Egalet's clinical trials, including the timely
recruitment of trial subjects and meeting the timelines therefor;
Egalet's ability to obtain and maintain regulatory approval of its
product candidates and the labeling claims that Egalet believes are
necessary or desirable for successful commercialization of its
products and 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 commercialize its products, and to do so successfully;
the costs of commercialization activities, including marketing,
sales and distribution; Egalet's ability to execute on its sales
and marketing strategy, including developing relationships with
customers, physicians, payors and other constituencies; the size
and growth potential of the markets for Egalet's products and
product candidates, and Egalet's ability to service those markets;
Egalet's ability to obtain reimbursement and third-party payor
contracts for its products; Egalet's ability to service or
refinance its debt obligations; Egalet's ability to raise
additional funds to execute its business plan and growth strategy
on terms acceptable to Egalet, if at all; Egalet's ability to find
and hire qualified sales professionals; the rate and degree of
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 the Risk
Factors set forth in Egalet's Annual Report on Form 10-K and
Quarterly Reports on Form 10-Q filed with the United States
Securities and Exchange Commission (SEC) and in other filings
Egalet makes with the SEC from time to time. In addition, the
forward-looking statements included in this press release represent
Egalet's views only as of the date hereof. Egalet anticipates that
subsequent events and developments may cause its views to change.
While Egalet may elect to update these forward-looking statements
at some point in the future, it specifically disclaims any
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: ir@egalet.com
Tel: 484-259-7370
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SOURCE Egalet Corporation