Pharmaceutical Manufacturing Research Services (PMRS) has filed a petition asking the U.S. Court of Appeals for the District of Columbia Circuit to overturn the U.S. Food and Drug Administration's refusal to approve a new opioid capsule intended to deter abuse through a novel combination of physical properties and labeling changes.
"We presented a product that updates the opioid Roxicodone with a use indication for limited dosing and acute pain," according to a statement from PMRS. "We are working hard to manage the risks associated with effective pain management. Our updated product and label respond to findings from the Centers for Disease Control that FDA-approved labeling of opioids for the treatment of 'chronic' pain is one of the drivers of the opioid crisis. We asked for an opportunity to address this problem with a new product and more appropriate labeling, but the FDA wouldn't even give us a hearing."
Many experts agree the opioid crisis can be traced to 2001, when the FDA labelled opioids for long-term treatment of "chronic" pain despite an absence of scientific research validating the safety and efficacy of such treatment, particularly against known addiction risks.
The FDA found the abuse deterrence language in PMRS's label "false and misleading" because the company did not supplement its laboratory tests of a dye – an unattractive color added to the capsule to discourage occasional misuse of the product by injection – with clinical studies proving that the color would actually discourage drug abusers.
According to PMRS, the dye "is the tail not the dog" on the issue of abuse deterrence, which PMRS addressed through both its product's formulation and new labeling that eliminates the chronic pain indication. The labeling is critical, the company explained, because limiting a prescription opioid's indication and dosing can help prevent the addiction that precipitates abuse.
PMRS's court filings say the FDA's refusal even to consider this approach ignores current science and the public interest, and is fundamentally unlawful.
"If FDA has a problem with specific language in our proposed label, it should modify the label, not disapprove the drug altogether," according to the company’s statement. "That is the approach the FDA has taken to other opioids with the 'chronic pain' indication. This country desperately needs a product that has the therapeutic properties of Roxicodone, but without the chronic pain indication that is still driving an ongoing national health emergency. This is no time to ignore novel solutions allowed by law and supported by science in order to protect a flawed regulatory regime built around the chronic use indication."