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 IPCI.TO 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 IPCI.O had not provided adequate data on the abuse potential of the drug as part of its U.S. marketing application.