WAYNE, Pa., Aug. 25, 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 researchers will present scientific data at PAINWeek 2016 on September 8 in Las Vegas. Four presentations will be on abuse-deterrent product candidate ARYMO™ ER (morphine sulfate) Extended-Release Tablets; one presentation will address abuse-deterrent properties of Egalet's proprietary Guardian™ Technology; and one presentation will be on marketed product OXAYDO® (oxycodone HCl, USP) tablets CII.
ARYMO ER was 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. ARYMO ER uses Egalet's proprietary Guardian™ Technology, a polymer matrix tablet technology which is combined with a novel application of the manufacturing process of injection molding. This 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, in order to deter common routes of abuse. 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. In addition, it is also the only approved immediate-release opioid designed to discourage abuse via snorting.
"Our presentations at PAINWeek will highlight the breadth of data on our product candidate ARYMO ER which uses Egalet's Guardian™ Technology to achieve both abuse-deterrent and extended-release properties," said Jeffrey Dayno, MD, Egalet's chief medical officer. "In addition, we also will present results from Category 1 abuse-deterrent experiments with OXAYDO, which assessed the challenges of syringeability and potential for abuse deterrence via the intravenous route of administration. We look forward to sharing these data with attendees at the upcoming PAINWeek conference."
The following posters will be presented during the PAINWeek 2016 poster session on Thursday, September 8 from 7:00 pm - 9:00 pm:
- Pharmacodynamic Effects from a Category 3 Oral Human Abuse Potential Study of an Abuse-Deterrent, Extended-Release Morphine Product Candidate in Nondependent, Recreational Opioid Users. Authors: Michael D. Smith, PharmD, Lynn R. Webster, MD, John Lawler, BS, Karsten Lindhardt, MSc, PhD, DBE, Jeffrey M. Dayno, MD.
- Pharmacodynamic Effects from a Category 3 Intranasal Human Abuse Potential Study of an Abuse-Deterrent, Extended-Release Morphine Product Candidate in Nondependent, Recreational Opioid Users. Authors: Lynn R. Webster, MD, Michael D. Smith, PharmD, John Lawler, BS, Karsten Lindhardt, MSc, PhD, DBE, Jeffrey M. Dayno, MD.
- Dissolution Studies in the Presence of Alcohol with an Abuse-Deterrent, Extended-Release Morphine Product Candidate. Authors: Torben Elhauge, MSc, Lene Kristensen, MSc, Karsten Lindhardt, MSc, PhD, DBE, Jeffrey Dayno, MD.
- Bioequivalence and Food Effect of a Novel, Abuse-Deterrent (AD), Extended-Release (ER) Morphine Product Candidate Compared with a Currently Available non-AD, ER Morphine Product. Authors: John Lawler, BS, Gwendolyn Niebler, DO, Karsten Lindhardt, MSc, PhD, DBE, Jeffrey M. Dayno, MD.
- Injection Resistance of an Immediate-Release Oral Oxycodone Hydrochloride Product with Abuse-Deterrent Properties. Authors: Torben Elhauge, MS, Edward J. Cone, PhD, August R. Buchhalter, PhD, Jeffrey M. Dayno, MD, Karsten Lindhardt, MSc, PhD, DBE.
- Correlating Viscosity and In Vitro Dissolution to In Vivo Pharmacokinetic Profiles of Proprietary Injection-Molded Tablet Formulations With Abuse-Deterrent Characteristics. Authors: Nikolaj Skak, MS, Torben Elhauge, MS, Martin Jan Øvergård, ELT, Karsten Lindhardt, MSc, PhD, DBE.
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.
IMPORTANT SAFETY INFORMATION
What is OXAYDO?
OXAYDO® (oxycodone HCl, USP) is an immediate-release oral formulation of oxycodone HCl for the treatment of acute and chronic moderate to severe pain where the use of an opioid pain medication is appropriate.
Risk of Abuse
OXAYDO is a Schedule II controlled substance with a risk for abuse similar to other opioid pain medications. 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.
Do not use OXAYDO if you have:
- Slowed breathing
- Very slow movement of your intestines or blocked intestines
- Acute or severe asthma
- Known allergy to oxycodone or any components of the product
- Inflamed pancreas
Serious side effects of OXAYDO may include:
- Slowed or stopped breathing, especially if you are:
- elderly or weakened
- suffering from conditions with low oxygen or air passageway blockage
- taking large doses of opioids for the first time
- taking other drugs that slow breathing
- suffering from chronic obstructive pulmonary disease (COPD) or heart problems associated with lung disease
- Cardiac arrest
- Low blood pressure
- Circulatory collapse or shock
- Worsening symptoms if taken with a head injury
- Greater effects such as slowed breathing, low blood pressure, significant sleepiness, or coma if OXAYDO is taken with medications that affect the central nervous system
- Severe low blood pressure if you have a problem maintaining your blood pressure
The most common side effects of OXAYDO are:
- Inability to sleep
Tell your doctor if you have:
- Severe kidney or liver disease
- Addison's disease
- Underactive thyroid function
- Enlarged prostate
- Difficulty urinating
- A seizure disorder
Some medications can interact with Oxaydo. Tell your doctor about all the medications that you take, especially if you take:
- Muscle relaxants
- Other pain medications
- Monoamine Oxidase Inhibitors (MAOIs)
Do not use alcoholic beverages, or any medications containing alcohol while taking OXAYDO.
Keep OXAYDO out of the reach of children.
OXAYDO may impair mental and/or physical abilities; use with caution with potentially hazardous activities.
To report SUSPECTED ADVERSE REACTIONS, contact Egalet US Inc. at 1-800-518-1084 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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: [email protected]
SOURCE Egalet Corporation