July 26 (Reuters) - A panel of independent advisers to the U.S. Food and Drug Administration concluded on Wednesday that there is not enough evidence to support the approval of Intellipharmaceutics International Inc’s long-acting opioid painkiller.
Toronto-based Intellipharma’s painkiller has been developed as a unique abuse-deterrent version of Purdue Pharma’s oft-abused blockbuster OxyContin, which already has tamper-resistant properties.
Most notably, the drug contains a blue dye that is emitted if the tablet is manipulated, which could help identify abusers, and a nasal irritant to discourage misuse.
In a preliminary review on Monday, FDA scientists raised concerns that Intellipharma had not provided adequate data on the abuse potential of the drug as part of its U.S. marketing application. (Reporting by Natalie Grover and Divya Grover in Bengaluru; Editing by Maju Samuel)