Newly Introduced Manipulation and Extraction Studies Designed to Satisfy FDA Requirements

A newly introduced product is designed to assist pharmaceutical manufacturers in satisfying FDA requirements for the introduction of abuse deterrent opioid formulations. These products are designed to address the epidemic increase in prescription pain reliever abuse and misuse by resisting physical and chemical alteration. The FDA issued its final guidance in April of this year on studies required of manufacturers to demonstrate efficacy of new products. Last week, DRUGSCAN® Pharmaceutical Services, a division of DRUGSCAN®, announced the introduction of CAT.oneTM laboratory-based manipulation and extraction studies, designed to satisfy Category 1 of the FDA guidance in this arena.

According to the manufacturer, studies enable the simulation of physical and chemical manipulation using the techniques that an experienced abuser might engage, including crushing, dissolution, syringe-ability, purification of active ingredients, smoke-ability, and dose dumping.

Are abuse deterrents working? Read about a survey, here.

Read about other forms of abuse deterrence, here.

Read a news release about the product introduction, including a link for more information from the manufacturer, here.




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