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 it will be co-hosting the 3rdCategory 1 Focus Group meeting (part of the Cross Company Abuse Liability Council Non-profit Organization) on January 30 and 31 in Alexandria, VA. The meeting is designed to bring together industry, researchers, the Food and Drug Administration (FDA) and other interested parties to discuss best practices in in vitro (Category 1) studies of abuse-deterrent formulations.
"This meeting continues to help advance the field of Category 1 abuse-deterrent studies which is a crucial step in the development of safer opioids," said Karsten Lindhardt, founder of the Category 1 Focus Group and chief scientific officer of Egalet. "We look forward to the discussions with individuals involved in research and development of abuse-deterrent products as well as representatives from the FDA. The meeting will have a focus on the new FDA guidance for developing generic abuse-deterrent opioids."
The objectives of the meetings are to:
- share experiences and best practices in Category 1 assessments of abuse-deterrent formulations;
- discuss standardization of Category 1 studies and the limits associated with established standard practices;
- provide an open forum and a society enabling discussion on the FDA Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling; and
- provide an opportunity for presentations by academia, regulatory and industry experts focused in the Category 1 field.
The meeting will be held at the Embassy Suites Hotel in Alexandria, VA. For more information about the meeting, please visit cat1focusgroup.com.

