Editorial Discussing Approaches to Category 1 Testing of Abuse-Deterrent Formulations of Opioids Published in Pain Practice

WAYNE, Pa., Sept. 27, 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 an editorial addressing approaches to Category 1 testing of abuse-deterrent formulations (ADFs) of opioids has been published in Pain Practice.

The editorial titled, "Striving for Consensus on Approaches to Category 1 Testing of Abuse-Deterrent Formulations of Opioids" was a result of a Category 1 Focus Group meeting held in November 2015 which Egalet helped organize that focused on best practices of in vitro assessments of ADFs and how to standardize procedures for Category 1 testing for products in development.

"The Category 1 Focus Group discussion highlighted the numerous challenges across the various methods of assessing an abuse-deterrent product and reinforced the importance of Category 1 studies as a critical piece of the puzzle when evaluating a new technology," said Karsten Lindhardt, senior vice president, research and development at Egalet, who, together with colleagues in the field, authored the editorial. "It is clear that more work needs to be done to standardize Category 1 testing where possible in relation to specific methods of manipulation; however, an iterative process is essential as abuse-deterrent formulations evolve and the AD properties of different product candidates may differ."

Key findings from the Category 1 Focus Group include:

• The Design of Category 1 study methodologies is highly dependent on the specific nature of the opioid, the abuse-deterrent features of the formulation and methods anticipated to be used by abusers to manipulate and administer the drug, which makes standardization challenging;
• Category 1, 2 and 3 testing should be performed with the to-be marketed product as small differences in a manufacturing process may impact the abuse-deterrent properties of that product;
• Level of effort is a critical component of Category 1 testing as recognized in the U.S. Food and Drug Administration (FDA) Guidance on Abuse-Deterrent Opioid Development;
  • However, there is no current guidance from the FDA on how to measure level of effort
• Category 1 studies provide useful information for the design of Category 2 and 3 studies; and
• Results from Category 1 studies are relevant for interpretation of data from Category 3 studies.

Dr. Lindhardt will present findings and perspectives from the Category 1 Focus Group meeting at the 3rd Human Abuse Liability & Abuse-Deterrent Formulations conference on November 3, 2016 in Arlington, VA. A second Category 1 focus group meeting is planned for March 2017.

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 (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: [email protected]
Tel: 917-432-9275

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SOURCE Egalet Corporation

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