WAYNE, Pa., May 28, 2015 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative pain treatments, today announced positive top-line results from Category 1 abuse-deterrent studies for Egalet-002, an abuse-deterrent, extended-release, oral oxycodone-based product in development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. The top-line results demonstrated that Egalet-002 resisted common and rigorous forms of physical manipulation used to defeat the tablet and snort—the most common route of abuse of oxycodone-based products.
The purpose of the studies was to perform a comprehensive, battery of laboratory tests to assess the physical and chemical properties of Egalet-002, with reformulated OxyContin (Oxycodone HCl extended-release tablets) serving as a comparator. These studies were conducted in accordance with the April 2015 Food and Drug Administration (FDA) Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling.
Highlights from the studies include:
· Because of the unique features of Egalet-002, which include an extremely hard outer shell surrounded by a hard inner core containing the API, both single step manipulation experiments, with a total of 11 household tools, as well as multi-step procedures, which included a total of 32 combination procedures, were conducted;
· Up to five times the effort was required to reduce the particle size of Egalet-002 compared to OxyContin;
· The percentage of the tablet amenable for snorting after the most vigorous attempts to defeat the products was 13 percent for Egalet-002 compared to 74 percent for OxyContin;
· Egalet-002 displayed high resistance to crushing and grinding with all household tools used in the studies, and pre-treatment by thermal stressing did not alter its resistance to physical manipulation attempts;
· Chemical manipulation and attempts at extraction with various solvents from both Egalet-002 and OxyContin were extremely difficult and yielded variable results; and
· Gelling of Egalet-002 occurred with all water-based solvents, indicating that Egalet-002 will not be amenable to abuse via injection.
"These Category 1 findings support the robust abuse-deterrent features of Egalet-002," said Edward J. Cone, Ph.D., principal scientist, Drug Delivery and Abuse Deterrent Drug Products, Pinney Associates. "The outer shell was nearly impossible to crush with blunt force which will help to prevent chewing of the product and accidental misuse, along with deliberate attempts to defeat the product for intranasal abuse as well as other common routes of abuse."
These studies were conducted by an independent laboratory in collaboration with recognized experts in the field of Category 1 abuse-deterrent study design and interpretation. The results confirm experiments previously conducted that showed Egalet-002's strong abuse-deterrent features. The full results from these Category 1 abuse-deterrent studies will be submitted for presentation at an upcoming scientific conference.
"The results of these Category 1 abuse-deterrent studies for Egalet-002, our abuse-deterrent, extended-release, oral oxycodone product candidate, demonstrate robust physical and chemical barriers to manipulation and incremental improvement for an extended-release oxycodone-based product," said Bob Radie, Egalet's president and chief executive officer. "We look forward to the results of our clinical human abuse liability studies for Egalet-002, being conducted with Oxycontin® as a comparator, to further elucidate the abuse-deterrent features of our product with the aim of bringing new treatment options to the market to reduce the overall burden of opioid misuse, abuse, overdose and death in our communities."
Egalet's Guardian Technology was developed to deliver commonly abused prescription medications in an abuse-deterrent form. The unique plastic injection molding manufacturing process results in abuse-deterrent features designed to resist the most common methods of abuse for morphine and oxycodone—injection and snorting, respectively. The Guardian Technology can be applied broadly across different classes of pharmaceutical products. Egalet's two lead abuse-deterrent product candidates, Egalet-001 and Egalet-002, are oral formulations of morphine and oxycodone respectively developed with the Guardian Technology to make particle size reduction difficult and resist dissolution. They are in late-stage clinical development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.
Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative pain treatments. The Company has two approved products: OXAYDO™ (oxycodone HCI, USP) tablets for oral use only –CII and SPRIX® (ketorolac tromethamine) Nasal Spray. In addition, using Egalet's proprietary Guardian™ Technology, the Company 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, Egalet-001, an abuse-deterrent, extended-release, oral morphine formulation, and Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation, are in late-stage clinical development 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. Full additional information on Egalet, please visit egalet.com.
Statements included in this press release 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 our clinical trials, including the timely recruitment of trial subjects and meeting the timelines therefor; our ability to obtain regulatory approval of our product candidates; ability to have third parties manufacture our products; competitive factors; our ability to find and hire qualified sales professionals; 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.