An advisory panel for the Food and Drug Administration (FDA) refused to recommend approval for Rexista, a long-acting opioid that is a bioequivalent to Purdue Pharma’s OxyContin, but with abuse-deterrent properties. The committee had strong reservations about whether the formulation could actually deter abuse and misuse of the powerful painkiller.
Rexista was developed by Intellipharmaceutics International Inc., to treat chronic pain that may require around-the-clock opioid treatment that can’t be treated adequately with other opioids. Long-acting opioids have become dangerous recreational drugs with users crushing the pills and sorting them or injecting them for a greater high.
Some drug companies have started manufacturing opioids with abuse-deterrent qualities that prevent them from being tampered with. The FDA has approved about 10 opioids with tamper-resistant qualities, but sales have been weak compared to older, less expensive opioids without abuse-deterrent properties.
Intellipharmaceutics International’s formulated Rexista with a blue dye that is released when the tablet is tampered with, which the drug maker said is designed to cause “stigmatization to the potential user.” It also contains an irritant to deter abusers from snorting it.
The FDA committee noted that Rexista was easier to crush into a fine dust than OxyContin. Intellipharmaceutics International said it did not formulate the medication to resist crushing.
The FDA is not required to follow the recommendation of its advisory panels, but it usually does.
Source: Practical Pain Management