WAYNE, Pa., May 5, 2016 /PRNewswire/ -- Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, announced today that researchers will present three scientific posters at the 35th Annual American Pain Society meeting May 11 to 14, 2016 in Austin, TX for ARYMO™ ER (morphine sulfate) extended-release tablets, an abuse-deterrent, oral morphine product candidate.
The clinical data to be presented demonstrate robust abuse-deterrent properties for ARYMO ER and an in vitro dissolution study showed no evidence of "dose dumping" in the presence of alcohol.
ARYMO ER has been 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. The U.S. Food and Drug Administration (FDA) accepted the new drug application (NDA) for ARYMO ER which was developed using Egalet's Guardian™ Technology. The FDA Prescription Drug User Fee Act (PDUFA) goal date for a decision on ARYMO ER is October 14, 2016.
The following posters will be presented at the American Pain Society poster session on Thursday, May 12.
- 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 (poster #422), Authors: Lynn R. Webster, MD, Michael D. Smith, PharmD, John Lawler, BS, Karsten Lindhardt, MSc, PhD, DBE, Jeffrey M. 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 (poster #430), Authors: Jeffrey M. Dayno, MD, John Lawler, BS, Gwendolyn Niebler, DO, Karsten Lindhardt, MSc, PhD, DBE
- Dissolution Studies in the Presence of Alcohol with an Abuse-Deterrent, Extended-Release Morphine Product Candidate (poster #425), Authors: Torben Elhauge, MSc, Lene Kristensen, MSc, Jeffrey M. Dayno, MD, Karsten Lindhardt, MSc, PhD, DBE
About The American Pain Society
Based in Chicago, the American Pain Society (APS) is a multidisciplinary community that brings together a diverse group of scientists, clinicians and other professionals to increase the knowledge of pain and transform public policy and clinical practice to reduce pain-related suffering. APS is the professional home for investigators involved in all aspects of pain research including basic, translational, clinical and health services research to obtain the support and inspiration they need to flourish professionally. APS strongly advocates expansion of high quality pain research to help advance science to achieve effective and responsible pain relief. For more information on APS, visit www.americanpainsociety.org.
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, opioid-based product candidates that are specifically designed to deter abuse by physical and chemical manipulation. The lead programs, ARYMO™ ER, formerly known as Egalet-001, 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.
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
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SOURCE Egalet Corporation