WAYNE, Pa., March 24, 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 study using the ALERRT instrument. The study showed that Egalet-002, an abuse-deterrent, extended-release oxycodone product candidate which uses Egalet's Guardian™ Technology, required significantly more effort to manipulate than OxyContin (oxycodone hydrochloride). The ALERRT instrument, which uses visual analog scales, is a tool developed by PinneyAssociates, Inc. to standardize how to quantify the level of effort required to manipulate an abuse-deterrent product candidate. The study was conducted in accordance with the U.S. Food and Drug Administration's (FDA) final Guidance for Industry, Abuse-Deterrent Opioids — Evaluation and Labeling (April, 2015), which states that "testing should provide information sufficient to fully characterize the product's abuse-deterrent properties, including the degree of effort required to bypass or defeat those properties."
"Egalet-002, a new oxycodone product candidate, has been shown in laboratory tests to be even more resistant to abuse than the currently marketed, abuse-deterrent OxyContin," said Ed Cone, PinneyAssociates. "These results demonstrate the strong potential for Egalet-002 to be a next generation abuse-deterrent, extended-release oxycodone."
Independent laboratory technicians performed ratings using the ALERRT instrument that employs a 100-point scale ranging from zero (very easy) to 100 (extremely difficult). Ten common household tools frequently used to manipulate abuse-deterrent opioids in Category 1 studies were utilized. Four products were tested including: Egalet-002 10 mg, Egalet-002 80 mg, Roxicodone 30 mg, a non-abuse-deterrent comparator, and OxyContin 40 mg, an abuse-deterrent comparator.
Top-line results from the study include:
- Egalet-002 was rated as moderately to extremely hard to physically manipulate (e.g., cut, crush, grind) on a tool by tool basis;
- The order of level of effort required to manipulate, from highest to lowest, was the following: 1) Egalet-002 80 mg, 2) Egalet-002 10 mg, 3) OxyContin 40 mg and 4) Roxicodone 30 mg;
- Based on this study using the ALERRT instrument, both Egalet-002 10 mg and 80 mg require significantly more effort to tamper as compared to both Roxicodone and OxyContin; and
- More instruments were damaged and/or broken when manipulating Egalet-002 compared to both Roxicodone and OxyContin.
"The difference shown between Egalet-002 and OxyContin is significant and supports the rigor of the Guardian Technology used to develop Egalet-002," said Karsten Lindhardt, Ph.D., senior vice president, head of research and development at Egalet. "Given the issue of prescription drug abuse, the level of effort required to manipulate a product may have important real world implications."To complete the full battery of abuse-deterrent studies, Egalet will be conducting Category 3 oral and intranasal human abuse potential studies to assess drug liking of Egalet-002 compared to both IR oxycodone and OxyContin.
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 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. 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.
Investor and Media Contact:
E. Blair Clark-Schoeb
Senior Vice President, Communications
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SOURCE Egalet Corporation