WAYNE, Pa., June 13, 2016 /PRNewswire/ -- Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, announced that scientific data presented today at the 78th Annual Meeting of the College on Problems of Drug Dependence (CPDD) in Palm Springs, CA show that Guardian Technology offers both abuse-deterrent (AD) features and precision drug delivery capabilities.
Egalet developed Guardian Technology, based on manufacturing using a proprietary injection molding process, result in tablets that are very hard and are expected to deter accidental misuse and intentional abuse. An extended-release profile is achieved by tablet polymer matrix erosion. The objective of this study was to test the hypothesis that strong AD features do not limit precision drug delivery, and correlations exist between the polymer viscosity, the in vitro dissolution profile, and the pharmacokinetic (PK) profile.
Highlights from the study included:
- Determined that the viscosity of the polymer incorporated in tablets manufactured using Guardian Technology enables prediction of the dissolution profile and the clinical PK profile;
- Tablet polymer viscosity can be used as a predictive tool in development of new AD products; and
- The flexibility of Guardian Technology allows for specific control of drug release, combination product development with different release profiles for each of the APIs, and/or tailoring of PK profiles.
“The CPDD data demonstrate the flexibility of drug release using Guardian Technology as it serves as a predictive tool in the development of new pharmaceutical products using injection molding,” said Karsten Lindhardt, Ph.D., senior vice president of research and development at Egalet. “This data supports the broad applications for Guardian Technology that go beyond abuse-deterrence and can be applied to a range of pharmaceutical products where precision delivery is essential to achieve an optimal product profile.”
The poster titled, ‘Correlating Viscosity and In Vitro Dissolution to In Vivo Pharmacokinetic Profiles of Proprietary Injection-molded Tablet Formulations with Abuse-Deterrent Characteristics’ was authored by Torben Elhauge, MS, Nikolaj Skak, MS, Martin Jan Øvergård, ELT, and Karsten Lindhardt, MSc, PhD, DBE, was presented today during the main poster session.
About The College on Problems of Drug Dependence
The College on Problems of Drug Dependence (CPDD) is the oldest and largest organization in the US dedicated to advancing a scientific approach to substance use and addictive disorders. CPDD actively promotes basic scientific research in all aspects of substance abuse, and facilitates the sharing of knowledge and new discoveries among scientists of diverse backgrounds, both nationally and internationally. CPDD also encourage the application of scientific knowledge to developing new behavioral and pharmacological treatment therapies through collaboration among academia, private industry, and government agencies, and help shape sensible and effective public policy by providing information and outreach to lawmakers at local, state, and national levels.
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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SOURCE Egalet
