July 24, 2017 / 2:03 PM / in 2 months

Abuse-liability data on Intelli's opioid drug missing - FDA staff

July 24 (Reuters) - U.S. Food and Drug Administration scientists on Monday raised concerns that Intellipharmaceutics International Inc failed to provide data from studies testing the abuse potential of its long-acting opioid painkiller.

Opioids are considered the gold standard in treating pain that persists despite other forms of therapy, but the rising wave of abuse is taking a toll on the healthcare system.

Health regulators have implemented a slew of measures of limit their supply, in particular requiring drugmakers to prove their painkillers are designed to discourage abuse, even as addicts devise fresher ways to get their fix.

Canada-based Intellipharma’s product, Rexista, has been developed as a unique abuse-deterrent version of Purdue Pharma’s OxyContin, which already has tamper-resistance properties.

Intellipharma’s formulation is designed to improve upon OxyContin in a number of ways, most notably in that it contains a blue dye designed to be emitted if the tablet is tampered with or crushed.

In a preliminary review posted ahead of a meeting of independent advisers on Wednesday, FDA scientists said that abuse-liability data had not been submitted as part of Rexista's marketing application. (bit.ly/2eHJpSH) (Reporting by Natalie Grover and Divya Grover in Bengaluru; Editing by Amrutha Gayathri)

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