WAYNE, Pa., Nov. 17, 2016 /PRNewswire/ -- Egalet
Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty
pharmaceutical company focused on developing, manufacturing and
marketing innovative treatments for pain and other conditions,
today announced the issuance of a United
States patent covering OXAYDO® (oxycodone HCI,
USP) tablets for oral use only–CII. Egalet licensed OXAYDO
from Acura Pharmaceuticals and launched the product in the United States in September 2015.
The United States Patent and Trademark Office (USPTO) issued
patent 9,492,443 broadly covering immediate-release pharmaceutical
compositions comprising an opioid formulated with Acura
Pharmaceutical's proprietary Aversion® Technology
intended to discourage common routes of abuse, including snorting.
The patent offers protection through 2024.
"This newly issued patent strengthens the overall protection for
OXAYDO and will be listed in the Orange Book alongside five other
patents covering OXAYDO," said Bob
Radie, president and chief executive officer of Egalet.
"Issuance of this patent further highlights the uniqueness of
the OXAYDO formulation, the only approved immediate-release
oxycodone designed to discourage abuse via one of the most common
routes of oxycodone abuse—snorting."
OXAYDO is indicated for the management of acute and chronic
moderate to severe pain where the use of an opioid analgesic is
appropriate. OXAYDO is the first and only immediate release
oxycodone product designed to discourage abuse via snorting because
of an inactive ingredient that may cause nasal burning if OXAYDO is
manipulated. 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.
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 upcoming milestones) 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 Egalet's product
candidates; Egalet's ability to maintain the intellectual property
position of Egalet's 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 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.
Media and Investor Contact:
E. Blair Clark-Schoeb
Senior Vice President, Communications
Email: bcs@egalet.com
Tel: 917-432-9275
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SOURCE Egalet Corporation