WAYNE, Pa., Dec. 1, 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 company has submitted to the
U.S. Food and Drug Administration (FDA) a supplemental new drug
application (sNDA) for OXAYDO® (oxycodone HCl, USP)
tablets C-II to support an abuse-deterrent label claim for the
intravenous route of abuse. The sNDA includes Category 1 in
vitro data that demonstrate OXAYDO resists extraction of oxycodone
and, based on its gelling properties, is more difficult to draw
into a syringe compared to a non-abuse-deterrent immediate-release
(IR) oxycodone comparator. OXAYDO is an IR oral formulation of
oxycodone HCl indicated for the management of acute and chronic
moderate to severe pain where the use of an opioid analgesic is
appropriate.
Immediate-release opioids account for 90 percent of the total
U.S. opioid market. An estimated 91 percent of all prescription
opioid abusers have abused immediate-release opioids. There are
currently no abuse-deterrent, IR opioids on the market today.
"The submission of this supplemental NDA for OXAYDO is part of
our broader strategy to strengthen and expand the label for
OXAYDO," said Jeffrey Dayno, MD,
chief medical officer at Egalet. "With the issue of abuse of
immediate-release opioids receiving more attention recently, we
look forward to working with the FDA as they review the data
submitted in this supplement."
OXAYDO is the first and only immediate-release oxycodone product
designed to discourage intranasal abuse. Through its novel, patent
protected formulation, OXAYDO contains an inactive ingredient that
may cause nasal burning if OXAYDO is manipulated and snorted. In an
intranasal human abuse potential double-blind, crossover study, six
times more recreational users reported they would not take OXAYDO
again compared to subjects exposed to immediate-release oxycodone
(30 percent of subjects exposed to OXAYDO responded they would not
take the drug again compared to five percent of subjects exposed to
IR oxycodone). The clinical significance of the difference in drug
liking and difference in response to taking the drug again reported
in this study has not yet been established. There is no evidence
that OXAYDO has reduced abuse liability compared to
immediate-release oxycodone.
The sNDA for OXAYDO includes data from a series of Category 1
studies that were presented at PAINWeek 2016. The sNDA will be a
standard FDA review which carries a six-month review timeline.
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.
Important Safety Information for OXAYDO® (oxycodone HCI, USP)
tablets for oral use only –CII
Indications and Usage
OXAYDO (oxycodone HCl, USP) is an immediate-release oral
formulation of oxycodone HCl indicated for the management of acute
and chronic moderate to severe pain where the use of an opioid
analgesic is appropriate.
Contraindications
OXAYDO is contraindicated in patients with respiratory depression,
paralytic ileus, acute or severe bronchial asthma or hypercarbia,
or known hypersensitivity to oxycodone or any components of the
product, or in any situation where opioids are contraindicated.
Warnings and PRECAUTIONS
Respiratory depression is a risk of OXAYDO, especially in elderly
or debilitated patients, in those suffering from conditions
accompanied by hypoxia, hypercapnia, or upper airway obstruction,
or following large initial doses of opioids given to non-tolerant
patients, or when given in conjunction with other agents that
depress respiration. Use with extreme caution in patients with
chronic obstructive pulmonary disease or cor pulmonale.
OXAYDO is a Schedule II controlled substance with an abuse
liability similar to other opioids. OXAYDO may be abused by
crushing, chewing, snorting or injecting the product and these
practices pose a significant risk to the abuser that could result
in overdose and death.
Patients receiving central nervous system depressants
concomitantly with OXAYDO may exhibit an additive central nervous
system depression, which may result in respiratory depression,
hypotension, profound sedation, or coma. Patients should not
consume alcoholic beverages, or any medications containing alcohol
while taking OXAYDO.
In the presence of a head injury or other intracranial lesions,
OXAYDO may cause markedly exaggerated elevation of intracranial
pressure.
OXAYDO may cause severe hypotension in patients whose ability to
maintain blood pressure has been compromised, may produce
orthostatic hypotension in ambulatory patients and must be
administered with caution in patients in circulatory shock.
Do not administer OXAYDO to patients with gastrointestinal
obstruction. Use OXAYDO with caution in patients with biliary tract
disease, including pancreatitis.
Use with caution and in reduced dosages in patients with severe
renal or hepatic impairment, Addison's disease, hypothyroidism,
prostatic hypertrophy, or urethral stricture, and in elderly or
debilitated patients. Use with caution when administering to
patients with CNS depression, toxic psychosis, acute alcoholism and
delirium tremens; may aggravate convulsions in patients with
convulsive disorders and may induce or aggravate seizures in some
clinical settings.
Keep OXAYDO out of the reach of children.
OXAYDO may impair mental and/or physical abilities; use with
caution with potentially hazardous activities.
Concomitant use of CYP3A4 inhibitors may increase opioid effects
and of CYP3A4 inducers may decrease effects or possibly cause
development of an abstinence syndrome in a patient who had
developed physical dependence to oxycodone.
Adverse Reactions
Serious adverse reactions that may be associated with OXAYDO
include: respiratory depression, respiratory arrest, circulatory
depression, cardiac arrest, hypotension, and/or shock.
The most common adverse reactions are nausea, constipation,
vomiting, headache, pruritus, insomnia, dizziness, asthenia and
somnolence.
Additional Drug Interactions
Muscle relaxants: enhances the neuromuscular blocking action of
skeletal muscle relaxants and produces an increased degree of
respiratory depression.
Mixed agonist/antagonist analgesics: may reduce the analgesic
effects and/or may precipitate withdrawal symptoms.
Monoamine Oxidase Inhibitors (MAOIs): use not recommended with
or within 14 days of stopping MAOIs.
Anticholinergics: increased risk for urinary retention and
severe constipation.
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