Menu Close

Remoxy ER (oxycodone) Extended-Release Capsules CII, based on Pain Therapeutics’ ORADUR technology, is a long-acting formulation of oxycodone designed to discourage most methods of tampering linked to opioid abuse.

However, a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee to the FDA voted 14 to 3 against approving the drug. And the FDA agreed and argued that the benefits of the drug did not outweigh the risks.

The company reacted badly.

“This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction,” said Remi Barbier, Pain Therapeutics’ president and chief executive officer, in a statement. “We have an innovative drug with a social purpose, and a staggering amount of data that easily supports best-in-class abuse deterrence versus OxyContin. We relied on the criteria of a fair, neutral and impartial regulatory review, as any sponsor would. Instead, I believe Remoxy received an ideological judgment call that is vague in nature but conclusive in its damaging effects.”

This is the companies fourth rejection on Remoxy. Seemingly in response to the rejection, Pain Therapeutics has launched a strategic reorganization. It plans to shift its focus from tamper-resistant opioid formulations to Alzheimer’s disease. Details are expected to be released in the upcoming weeks.

The FDA has perhaps changed direction on approval of opioid pain management strategies. They have announced “we must also take steps to help those with acute and chronic pain who need access to medicines, including opioids, get improved treatment alternatives.”

“Transitioning from the current market, dominated by conventional opioids, to one in which most opioids have abuse-deterrent properties, holds significant promise for a meaningful public health benefit. While these innovative formulations are designed to make it harder for people to manipulate the opioid drug so they can’t be abused, it’s important that prescribers and patients understand that these drugs are not ‘abuse-proof,’ and they do not prevent addiction, overdose, or death.”

“In addition, part of our ongoing work is ensuring that drug approval and removal decisions are made within a benefit/risk framework that evaluates not only the outcomes of opioids when used a prescribed, but also the public health effects of inappropriate use of these drugs. We are continually re-evaluating the safety of approved opioid products based on both post-market data the FDA has required from sponsors and additional sources of information as part of our safety surveillance.”

Both the announced policy and the FDA current opioid rejection history seem to indicate a trend away from opioid drugs toward “alternatives,” whatever that might be.