WAYNE, Pa.,
Sept. 8, 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 Category 1 abuse-deterrent
data presented at PAINWeek 2016 demonstrate that OXAYDO® (oxycodone
HCl, USP) tablets CII resist syringeability which could potentially
deter abuse through the intravenous route.
The data from a series of Category 1 studies of
syringeability which assess abuse deterrence via the intravenous
route of administration showed that OXAYDO forms a highly viscous
gel that resisted preparation for injection and attempts to isolate
oxycodone after manipulation. These results suggest that OXAYDO
presents significant barriers to abuse via the intravenous route of
administration. The data also demonstrated that the extraction of
oxycodone from OXAYDO was significantly more difficult than from
the comparator—a marketed generic immediate-release
oxycodone.
"The Category 1 abuse-deterrent data for OXAYDO suggest
that it may be difficult to abuse via the intravenous route," said
Jeffrey Dayno, MD,
chief medical officer at Egalet. "Because the IV route of
abuse poses the greatest safety risk, this is important additional
data for OXAYDO which is the only marketed immediate-release opioid
designed to discourage abuse via the intranasal
route."
OXAYDO 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.OXAYDO is designed to discourage
intranasal abuse through its novel, patent protected formulation.
The product 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.
In addition to the OXAYDO data, five other posters are
being presented during the PainWeek 2016 poster session today,
Thursday, September 8, from
7:00 pm - 9:00 pm. Four of the
posters showcase data that demonstrate ARYMO™ ER
(morphine sulfate) extended-release tablets has lower potential for
abuse after manipulation and being taken orally or intranasally,
does not dose dump in the presence of alcohol and does not have a
clinically significant interaction with food. The fifth poster
highlights data generated using Guardian™ Technology which show
that tablet polymer viscosity can be used as a predictive tool in
the development of new abuse-deterrent products as well as other
applications.
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