Boston, MA 04/01/2014 (wallstreetpr) – Specialty pharmaceutical company, Egalet Corp (NASDAQ:EGLT), has announced positive results for Phase 1 study of its Egalet-001, an abuse deterrent oral morphine product that is being developed for the treatment of severe chronic pain. Egalet-001 uses Eaglet’s proprietary technology which is designed to prevent any physical and chemical manipulation.
Phase 1 study Results
Egalet Corp (NASDAQ:EGLT) is currently carrying out studies to evaluate the products deterrent properties in accordance with Food and Drug Administration guidance commonly referred to as “Abuse-Deterrent Opioids-Evaluation and Labelling”. The first phase of the study was aimed at testing Egalet-001’s ability to prevent a broad range of common methods of physical manipulation, including crushing through the use of readily available items such as spoons and knives.
The Studies have already shown that Egalet-001 has the capacity to stop common forms of physical manipulation as compared to MS Contin. An independent laboratory carried out a test on a number of household tools in a bid of trying to reduce the particle size for abuse purposes. The results from this study showed similar results conducted by Eaglet’s Laboratory on the effectiveness of Egalet-001’s to provide strong abuse deterrence features.
Egalet Corp (NASDAQ:EGLT)’s president and Chief executive officer has been quick to point out how Egalet-001 is effective in providing good resistance compared to oral morphine,going as far as showing massive improvement when compared to other treatment options in the market. The latest development comes at the back of Egalet receiving Fast Track designation from the FDA for Egalet-001.
Phase II Studies
Egalet Corp (NASDAQ:EGLT) is now moving to the next stage of testing with a view of trying to demonstrate the effectiveness of Egalet-001 as an abuse deterrent. Success in this stage will mark another milestone for the company as individuals with moderate to severe chronic pain will essentially be provided with effective medicines that are safe for consumption while acting as abuse-deterrent.
The second phase of the study will focus on trying to extract active pharmaceutical ingredient (API) from the matrix using household solvents. Categories 2 and 3 for abuse deterrence studies will be initiated in the second quarter of 2014 parallel with pharmaceutical company’s plan, to carry out a pivotal bioequivalence studies with a view of comparingEgalet-001 and MS Contin.
