HORSHAM, Pa., Aug. 5, 2015 /PRNewswire/ -- DRUGSCAN© Pharmaceutical Services, a division of DRUGSCAN©, announced the introduction of CAT.one laboratory-based manipulation and extraction studies, designed to satisfy the US Food and Drug Administration’s (FDA) requirements for abuse-deterrent opioid pharmaceutical products.
To address the epidemic rise in prescription opioid drug abuse, pharmaceutical companies have been developing opioid pain relievers that resist physical and chemical manipulation techniques used by drug abusers. In April 2015, the FDA issued final guidance on what studies pharmaceutical companies would need to conduct to demonstrate that their products deter common methods of abuse. The studies within the guidance are broken down into four categories. Category 1 is manipulation and extraction studies.
The CAT.one laboratory-based manipulation and extraction studies have been designed to satisfy the FDA requirements for Category 1 abuse deterrent labeling claims. Using state of the art technology and techniques, DRUGSCAN© Pharmaceutical Services has been at the forefront in testing abuse-deterrent opioids.
“With our CAT.one studies, pharmaceutical companies can demonstrate that their products deter methods of opioid manipulation including crushing, grinding, dissolving in solvents and heating or freezing,” said Dr. Anthony Costantino, Ph.D., President and CEO of DRUGSCAN©. “Data generated from these studies can support critical Category 1 labeling claims for our pharmaceutical partner’s abuse- deterrent opioids.”
CAT.one studies are designed and conducted under a rigorous scientific, regulatory and good laboratory practice (GLP) environment. CAT.one scientists simulate physical and chemical manipulations using household tools or experienced abuser’s techniques including crushing, dissolution, syringe-ability, purification of active ingredients, smoke-ability, and dose dumping.
“Prescription drug abuse is a serious problem in the United States,” said Dr. Costantino. “We are proud to work with our pharmaceutical partners in addressing this national epidemic.”
For more information about CAT.one laboratory-based manipulation and extraction studies, please call DRUGSCAN© Pharmaceutical Services at 800-235-4890 or Email.
About DRUGSCAN©
DRUGSCAN© is a leader in clinical and forensic toxicology, medication monitoring, and drug detection laboratory services. DRUGSCAN© has been certified by the Substance Abuse and Mental Health Services Administration (SAMHSA) since 1989 and is accredited by the College of American Pathologists (CAP), ensuring consistently high levels of service, compliance with regulations, and achievement of the highest standards of accuracy, professionalism and responsiveness. For more about DRUGSCAN©, please visit www.drugscan.com
Media Contact:
Greg Gironda
800-235-4890
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/catone-manipulation-and-extraction-studies-satisfy-fda-requirements-for-abuse-deterrent-opioids-300123955.html
SOURCE DRUGSCAN(C) Inc.
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