FDAnews Drug Daily Bulletin

PMRS Petitions Against FDA Approval For Chronic Pain Opioid NDA

July 27, 2017

Pharmaceutical Manufacturing Research Services called on the FDA not to approve a chronic pain opioid NDA from Intellipharmaceutics.

In a citizen petition, PMRS asked the agency to deny the pending NDA as well as any other pending applications for opioids indicated for chronic use. This indication, the petition states, lacks substantial evidence based on adequate investigation as required under the FD&C Act. It also contradicts CDC recommendations against use of opioids for chronic pain.

Such uses, the petition states, are particularly dangerous amid the ongoing opioid addiction crisis. The risk of addiction is particularly high for long-acting opioids, PMRS said.

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