Egalet Announces Scientific Presentations at PAINWeek 2016 Meeting

PRNewswire: August 25, 2016 – WAYNE, PA, U.S.A. – 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 that 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 to 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