Egalet Human Abuse Potential Data At American Pain Society Annual Meeting Demonstrates Significantly Lower Intranasal Abuse Potential Of ARYMO ER Compared To MS Contin
WAYNE, Pa., May 12, 2016 /PRNewswire/ -- Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, presented data at the 35th Annual American Pain Society annual meeting demonstrating that ARYMO ER (morphine sulfate) extended-release tablets, an abuse-deterrent, oral morphine product candidate, had significantly lower drug liking scores compared to MS Contin® (morphine sulfate extended-release tablets) CII. The Category 2/3 intranasal human abuse potential (HAP) study showed no relevant food effect with ARYMO ER, while an in vitro dissolution study showed no evidence of alcohol dose dumping. 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, ARYMO ER was created using Egalet's proprietary Guardian Technology. The U.S. Food and Drug Administration (FDA) accepted the new drug application (NDA) for ARYMO ER and it is currently under review. The FDA Prescription Drug User Fee Act (PDUFA) goal date for a decision on ARYMO ER is October 14, 2016.
Highlights of the data from the three posters include:
- A Category 2/3 clinical intranasal HAP study of 46 subjects comparing the pharmacokinetic (PK) profile and abuse potential of ARYMO ER and MS Contin demonstrated that:
- A higher level of effort was initially required to physically manipulate ARYMO ER to prepare it for insufflation compared with the ease of crushing MS Contin into a fine powder;
- 'Overall drug liking' was significantly reduced for ARYMO ER (51 on the 100-pt bipolar overall drug liking Visual Analog Scale [VAS]) compared to MS Contin (71; p < 0.0001) and was similar to placebo (50);
- The response to 'take drug again' was significantly lower for ARYMO ER (50 on the 100-pt bipolar take drug again VAS) compared to MS Contin (73; p < 0.0001) and was similar to placebo (50);
- the Abuse Quotient (AQ: Cmax or maximum plasma concentration/Tmax or time to Cmax), a PK indicator of abuse potential, was much lower for ARYMO ER (2.3 9.2) compared to MS Contin (37.2)
- In a clinical food effect study, ARYMO ER in the fed state was bioequivalent to the product dosed in a fasted state; thus, no clinically significant interaction with food was observed with ARYMO ER
- In an in vitro alcohol interaction study, there was no evidence of dose dumping of ARYMO ER in the presence of various concentrations of ethanol; in fact, the release of morphine from ARYMO ER was slower with increasing concentrations of alcohol
"The data support a strong, clinically relevant abuse-deterrent profile for ARYMO ER," said Jeffrey Dayno, MD, chief medical officer at Egalet. "The PK data demonstrate no significant food effect so that ARYMO ER can be taken without regard to food. The data also show no evidence of alcohol dose dumping, an important safety aspect of the product. These findings from our extensive abuse-deterrent development program support a robust profile for ARYMO ER based on both the pharmacokinetic and pharmacodynamic results from a Category 2/3 intranasal human abuse potential study."
About The American Pain Society
Based in Chicago, the American Pain Society (APS) is a multidisciplinary community that brings together a diverse group of scientists, clinicians and other professionals to increase the knowledge of pain and transform public policy and clinical practice to reduce pain-related suffering. APS is the professional home for investigators involved in all aspects of pain research including basic, translational, clinical and health services research to obtain the support and inspiration they need to flourish professionally. APS strongly advocates expansion of high quality pain research to help advance science to achieve effective and responsible pain relief. For more information on APS, visit www.americanpainsociety.org.
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.
Media and Investor Contact:
E. Blair Clark-Schoeb
Senior Vice President, Communications
Email: bcs@egalet.com
Tel: 917-432-9275
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