Pain Therapeutics Blasts FDA After Remoxy Meeting
Pain Therapeutics says that at a 1/31 meeting with FDA to discuss its drug candidate Remoxy ER, it learned that (1) FDA denies making math errors, material mistakes, or misrepresentations during a 6/2018 advisory committee meeting for Remoxy, “despite clear evidence to the contrary”; (2) comparator data is irrelevant for the evaluation of abuse-deterrent properties, “despite FDA written guidance which explicitly states the opposite”; and (3) the company would need to rely on the Freedom of Information Act to access additional data generated by FDA with Remoxy.
“As a result of our recent meeting with FDA, we believe we are no closer today to product approval than we were over a year ago,” the company says in a statement. “We had hoped for a fair, neutral, and impartial review of the Remoxy data. Instead, we walked out of this meeting feeling a bit disoriented by FDA’s lack of transparency, clarity, or helpfulness. It’s a rare occasion when two parties can’t agree on simple math. We can’t work with shambolic regulations. This is not how you win support for innovation.”
The company particularly criticizes FDA for its review of the drug’s abuse-deterrence properties. “Studies were designed in consultation with FDA and conduced by independent labs,” it declares. “Collectively, we believe these studies adequately characterize Remoxy’s abuse-deterrent properties. In particular, we demonstrated that the two currently marketed extended-release oxycodone products (OxyContin and Xtampza), which both benefit from abuse-deterrent label claims, can both be defeated for purposes of abuse in under a minute using common household items. In contrast, Remoxy requires a significant investment of time, effort, and equipment to defeat, and even then results in less release of oxycodone. During our recent meeting with FDA we were informed they believe Remoxy capsules lack abuse deterrence via the injection route of abuse because ‘oxycodone can be extracted from the product,’ regardless of how much time, effort, frustration, or equipment is required to do so. We are unable to follow the logic by which a drug product should never release drug. More generally, as the regulatory requirements for Remoxy have changed frequently and suddenly over time, we have experienced significant delays and have incurred unanticipated expenses related to the overall Remoxy development program.”
Remoxy has been before FDA for several years and has been consistently rejected in agency reviews and advisory committee consideration. Pain Therapeutics says that while there are procedures in place at FDA and other government agencies to help promote a fair resolution of disputes, they are complex and may not be rapid, predictable, or even viable. “Going forward,” it concludes, “we will generally be silent regarding our plans or future expectations for Remoxy, unless a significant material event occurs that compels is to update our public disclosures around this product candidate.”