Egalet Announces Positive Top-Line Results From An Intranasal Human Abuse Potential Study Of Egalet-002

WAYNE,Pa., Dec. 16, 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 positive top-line results from a Category 3 intranasal human abuse potential (HAP) study of Egalet-002, an abuse-deterrent, extended-release oxycodone product candidate which uses Egalet's Guardian Technology. Egalet-002 is in late-stage development 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 Logo. (PRNewsFoto/Egalet Corporation)

"Given that intranasal abuse is the most common form of non-oral oxycodone abuse, these results, having hit the primary endpoint of reduced maximum drug liking, are promising," said Bob Radie, president and chief executive officer. "We will look to submit the full data for presentation at a medical meeting in 2017."

Egalet-002 was designed using a version of Egalet's proprietary Guardian Technology that contains an inner matrix and an exterior shell. 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. The physical hardness of the tablet and the gelling effect of the matrix are designed to give Egalet-002 its physical and chemical abuse-deterrent characteristics.

The study was a randomized, double-blind, active and placebo-controlled 6-period crossover study. The study evaluated the abuse potential of manipulated Egalet-002 compared to crushed immediate-release (IR) oxycodone through the nasal route in 46 non-dependent recreational opioid users experienced in nasal insufflation. A comparison to manipulated OxyContin (oxycodone hydrochloride) was also included as an exploratory arm. The study was conducted in accordance with the FDA's Guidance for Industry, Abuse-Deterrent Opioids ” Evaluation and Labeling (April, 2015), and used more aggressive methods of manipulation for Egalet-002 identified from the Category 1 in vitro laboratory studies which were needed to get Egalet-002 into a snortable form.

The treatment periods included: Egalet-002 40 mg (manipulated with shell on), Egalet-002 40 mg (manipulated with shell taken off through an additional manipulation step), crushed IR oxycodone 40 mg, manipulated OxyContin 40 mg, manipulated Egalet-002 placebo tablet, and placebo powder. The primary study endpoint was Drug Liking measured on a bipolar 100-point scale, where 50 is neutral, 100 is maximum liking and 0 is maximum disliking.

Top-line results from the study include:

  • For the primary comparison, the difference in maximum Drug Liking (Emax) between manipulated Egalet-002 (with shell on; 79.5) was significantly lower compared to crushed IR oxycodone (86.6); p = 0.0004
    • This outcome was also significant for the comparison between manipulated Egalet-002 (with shell off; 77.4) and crushed IR oxycodone (86.6); p < 0.0001
  • For the secondary outcome of Take Drug Again (measured on a bipolar 100-point scale), the results were 69.9 for manipulated Egalet-002 (shell on), 72.4 for manipulated Egalet-002 (shell off), and 75.5 for crushed IR oxycodone; not statistically significant for either comparison
  • In the exploratory analysis with OxyContin, Emax Drug Liking was similar in all treatment arms: manipulated Egalet-002 (with shell on; 79.5), manipulated Egalet-002 (with shell off; 77.4), and manipulated OxyContin (76.2)
    • Ease of Snorting and Pleasantness of Snorting were also assessed using unipolar 100-point scales where 100 represented 'very easy'/'very pleasant' and 0 meant 'very hard'/'very unpleasant'; results were as follows:
      • Ease of Snorting was significantly harder for manipulated Egalet-002 (with shell on; 42.0) and manipulated Egalet-002 (with shell off; 49.5) compared to manipulated OxyContin (65.1); p < 0.0001 and p = 0.0050, respectively
      • Pleasantness of Snorting was significantly lower for manipulated Egalet-002 (with shell on; 40.7) and manipulated Egalet-002 (with shell off; 44.7) compared to manipulated OxyContin (55.3); p = 0.0003 and p = 0.0081, respectively

Guardian Technology
Egalet's Guardian Technology has many applications and has been used to develop abuse-deterrent forms of commonly abused prescription medications. Egalet's proprietary Guardian Technology is a polymer matrix tablet technology that utilizes a novel application of the well characterized manufacturing process of injection molding, which results in tablets that are more difficult to manipulate for misuse and abuse. This approach offers the ability to design tablets with controlled-release profiles as well as physical and chemical properties that have been demonstrated to resist both common and rigorous methods of manipulation. Tablets manufactured with Guardian Technology have been shown to have increased resistance to physical methods of manipulation, such as cutting, crushing, grinding or breaking using a variety of tools. They are also resistant to chemical manipulation and extraction and turn into a viscous hydrogel on contact with liquid, making syringeability very difficult. Egalet-002 was designed using a version of Egalet's proprietary Guardian Technology that contains an innermatrix and an exterior shell while ARYMO ER uses a different version of the Guardian Technology.

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.

Safe Harbor
Statements included in this press release that are not historical in nature and contain the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "look forward to" and other similar expressions 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 to execute its business plan and growth strategy on 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 the Risk Factors set forth in Egalet's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the United States Securities and Exchange Commission (SEC) and in other filings Egalet makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent Egalet's views only as of the date hereof. Egalet anticipates that subsequent events and developments may cause its views to change. While Egalet may elect to update these forward-looking statements at some point in the future, it specifically disclaims any 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.

OXYCONTIN is a registered trademark of Purdue Pharma L.P.

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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