Egalet Announces Scientific Data at PAINWeek 2015 Meeting Supports Analgesic Efficacy of SPRIX® Nasal Spray Versus Commonly Prescribed Oral Combination Opioids in Treatment of Moderate to Severe Short-Term Pain

Egalet Corporation

("Egalet"), a fully integrated specialty pharmaceutical company focused on discovering, developing and commercializing innovative pain treatments, today announces the presentation of scientific data at PAINWeek 2015 from a meta-analysis that shows that the treatment effect sizes of SPRIX® (ketorolac tromethamine) Nasal Spray were similar or higher than combination opioid products supporting the use of SPRIX Nasal Spray as an effective treatment option for patients who require analgesia at the opioid level. In addition, data from Category 3 human abuse liability studies being presented demonstrate the robust abuse-deterrent profile of Egalet-001, an abuse-deterrent, extended-release morphine product candidate 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. Finally, a Category 1 abuse-deterrent study being presented demonstrates the strong physical abuse-deterrent characteristics of Egalet's abuse-deterrent, extended-release oxycodone product candidate, Egalet-002, compared to OxyContin® (oxycodone hydrochloride). Egalet Logo. SPRIX Nasal Spray, a non-steroidal anti-inflammatory drug (NSAID), is approved in adults for short-term (up to five days) management of moderate to moderately severe pain that requires analgesia at the opioid level. SPRIX is available with a prescription through Sprix Direct. "Our data at PAINWeek this year highlight the breadth of Egalet's products, including the data on SPRIX Nasal Spray that demonstrates how this unique product offers patients and physicians an effective treatment option with opioid-level pain relief," said Jeffrey Dayno, MD, Egalet's chief medical officer. "In addition, data on our Guardian™ Technology product candidates support the robust abuse-deterrent profiles of both Egalet-001 and Egalet-002. We will be submitting the results of these studies for publication in the near future." Egalet-001 was designed using Egalet's proprietary Guardian™ Technology that is a polymer matrix tablet technology which is combined with a novel manufacturing process, plastic 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 more rigorous methods of manipulation, in order to deter common routes of abuse. Data demonstrating statistically significant reduction in maximal drug liking for Egalet-001 compared to MS Contin® (morphine sulfate extended-release tablets) through both oral and intranasal routes of abuse are being presented this week based on the results of Category 3 oral human abuse liability (HAL) and intranasal HAL studies. "The data from both the oral and intranasal HAL studies demonstrate the robust abuse-deterrent profile of Egalet-001—the potential first abuse-deterrent, extended-release morphine product using a physical and chemical barrier approach to abuse deterrence," said Lynn Webster, MD, Vice President, Scientific Affairs, PRA International. "Given that morphine is the most prescribed extended-release opioid, combined with the growing issue of opioid abuse, Egalet-001 represents a clinically relevant treatment option that, if approved, could help deter abuse as well as help to decrease the problem of opioid addiction, overdose and death occurring in our communities." The five posters containing data on Sprix Nasal Spray, Egalet-001, and Egalet-002 will be presented this evening, Thursday, September 10, during the main poster session. Abstract Highlights SPRIX® Nasal Spray The treatment effect sizes of SPRIX Nasal Spray were similar to or higher than common oral combination opioid products in the setting of postoperative pain after third molar surgery, a well-accepted acute pain model, supporting SPRIX as an effective treatment option for patients with moderate to moderately severe short-term pain. Egalet-001 The level of work measured using ALERRTSM (Assessing Labor, Effort and Resources Required for Tampering), a tool developed by PinneyAssociates to standardize how to quantify the level of effort required to defeat an abuse-deterrent product candidate, was applied to evaluate the level of effort required to manipulate Egalet-001 compared to MS Contin; results showed that it took up to ten times greater level of effort and time to manipulate Egalet-001 compared to MS Contin; In a Category 3 intranasal HAL study, after maximal manipulation which took more effort for Egalet-001 compared to MS Contin, Egalet-001 demonstrated a statistically significant reduction in maximal drug liking (Emax; primary endpoint) compared to MS Contin (p < 0.001) with a much lower Abuse Quotient (Cmax/Tmax) based on PK data; and, Similar results were reported from a Category 3 oral HAL study, in which subjects reported significantly lower drug liking Emax for manipulated Egalet-001 compared to the Emax for manipulated MS Contin (p = 0.007). Egalet-002 Based on Category 1 physical abuse-deterrent studies, Egalet-002 resisted manipulation for up to five-times the duration of effort required for failure of OxyContin; when Egalet-002 was subjected to equivalent effort, the particle size reduction outcome was far less successful and yielded one-sixth the particle size output that would be amenable for snorting as compared to OxyContin.