Egalet Announces Scientific Presentations at PainWeek 2015 Meeting

--Data demonstrate efficacy of SPRIX® Nasal Spray for acute pain compared to combination opioid products and strong abuse-deterrent profile of Egalet-001 and Egalet-002--

Sep 01, 2015, 06:00 ET from Egalet Corporation

WAYNE, Pa., Sept. 1, 2015 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on discovering, developing, and commercializing innovative pain treatments, today announced that researchers will be  presenting scientific data on SPRIX® (ketorolac tromethamine) Nasal Spray, Egalet-001, an abuse-deterrent, extended-release, oral morphine product candidate, and Egalet-002, an abuse-deterrent, extended-release, oral oxycodone product in development, at PainWeek 2015 to be held September 8 to 12 in Las Vegas, Nevada.

SPRIX Nasal Spray, a non-steroidal anti-inflammatory drug (NSAID), is indicated in adult patients for the short-term (up to five days) management of moderate to moderately severe pain that requires analgesia at the opioid level, and is available with a prescription through Sprix Direct. Egalet's Guardian™ Technology product candidates Egalet-001 and Egalet-002 are in late-stage development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.

"This is an exciting time for Egalet as we will be presenting efficacy data for one of our approved products, SPRIX Nasal Spray, showing how it is an effective treatment option compared to combination opioid products for adult patients with moderate to moderately severe short-term pain and data that demonstrates the abuse-deterrent profiles of our late-stage product candidates, Egalet-001 and Egalet-002, developed using our proprietary Guardian Technology," said Jeffrey Dayno, MD, Egalet's chief medical officer. "We look forward to sharing these data with those attending the upcoming PainWeek conference."

The following posters will be presented during the PainWeek 2015 poster session on Thursday, September 10 from 7:00 pm - 9:00 pm:

  • Comparison of the Effect Sizes of Ketorolac Nasal Spray and Commonly Prescribed Oral Combination Opioids in Moderate to Severe Short-Term Pain (Poster #86), Authors: Gwendolyn Niebler, DO, Jeffrey Dayno, MD, and Robert Axford-Gatley, MD
  • Extreme Work Requirement of EG-001, an Abuse-Deterrent, Extended-Release Morphine Product as Demonstrated With the ALERRTSM Visual Analog Scales (Poster #30), Authors: Edward J. Cone, PhD, August R. Buchhalter, PhD, Karsten Lindhardt, MSc, PhD, DBE, Torben Elhauge, MS, Jeffrey Dayno, MD
  • Human Abuse Potential of an Abuse-Deterrent (AD), Extended-Release (ER) Morphine Product Candidate (EG-001) Versus a Currently-Available non-AD, ER Morphine Product Administered Orally in Nondependent, Recreational Opioid Users (Poster #121), Authors: Michael Smith, PharmD, Lynn Webster, MD,  John Lawler, BS, Jeffrey Dayno, MD
  • Human Abuse Potential of an Abuse-Deterrent (AD), Extended-Release (ER) Morphine Product Candidate (EG-001) Versus a Currently-Available non-AD, ER Morphine Product Administered Intranasally in Nondependent, Recreational Opioid Users (Poster #136), Authors: Lynn Webster, MD, Michael Smith, PharmD, John Lawler, BS, Jeffrey Dayno, MD
  • EG-002, a Novel Proprietary Abuse-Deterrent, Extended-Release Formulation of Oxycodone Demonstrates Strong Abuse-Deterrent Potential Based on the Results From a Category 1 In Vitro Physical Manipulation Study (Poster #31), Authors: Edward J. Cone, PhD, August R. Buchhalter, PhD, Karsten Lindhardt, MSc, PhD, DBE, Torben Elhauge, MS, Jeffrey Dayno, MD

About Egalet
Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative pain treatments. The Company has two approved products: OXAYDO (oxycodone HCI, USP) tablets for oral use only –CII and SPRIX® (ketorolac tromethamine) Nasal Spray. In addition, using Egalet's proprietary Guardian™ Technology, the Company 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, Egalet-001, an abuse-deterrent, extended-release, oral morphine formulation, and Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation, are in late-stage clinical development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments 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. Full additional information on Egalet, please visit www.egalet.com.

Important Safety Information for SPRIX® (ketorolac tromethamine) Nasal Spray
SPRIX® is a non-steroidal anti-inflammatory drug (NSAID) indicated in adult patients for the short-term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.  Do not exceed a total combined duration of use of SPRIX and other ketorolac formulations (IM/IV or oral) of 5 days. SPRIX is not indicated for use in pediatric patients or for minor or chronic painful conditions.

SPRIX is contraindicated as follows: in patients with peptic ulcer disease or a history of GI bleeding; in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or at high risk of bleeding; for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery; in patients with advanced renal impairment and those at risk for renal failure due to volume depletion; use as a prophylactic analgesic before any surgery; use in labor and delivery; use in patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; and, known hypersensitivity to ketorolac, aspirin, other NSAIDs or EDTA. 

SPRIX should be used with caution in patients with a prior history of ulcer disease or GI bleeding, coagulation disorders, in patients taking diuretics or ACE inhibitors, or those with compromised cardiac function.  NSAIDs can cause serious anaphylactoid reactions and serious dermatologic adverse reactions; SPRIX should be discontinued immediately in patients with allergic reactions or skin reactions.

The most common adverse reactions (incidence > 2%) in patients treated with SPRIX and occurring at a rate at least twice that of placebo are nasal discomfort, rhinalgia, increased lacrimation, throat irritation, oliguria, rash, bradycardia, decreased urine output, increased ALT and/or AST, hypertension, and rhinitis.

SPRIX is not an inhaled product. SPRIX nasal spray should be discarded within 24 hours of taking the first dose, even if the bottle still contains some medication.

Please see full prescribing information for SPRIX at www.sprix.com.

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.

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



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