Durect’s post-op painkiller splits FDA advisory panel

As the US opioid addiction crisis continues, it seems the FDA is less than convinced about the new painkilling drugs that the pharma industry is developing.

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) already unanimously voted last week that Nektar’s long-acting opioid oxycodegol, or NKTR-181, should not be approved.

The panel was concerned about a lack of evidence of abuse-deterrent measures, and the feedback from the 27-0 vote was so bad that Nektar opted to pull the drug’s filing, even though the committee’s decision is only advisory.

After Nektar’s mauling it was Durect’s turn to face the panel with its POSIMIR (bupivacaine extended-release solution), an investigational post-operative pain relief depot product.

Posimir is designed to be administered directly into the surgical site to deliver bupivacaine for up to three days after surgery.

It didn’t go much better for Durect as the AADPAC vote was split with six advisory committee members voting in favour, and six deciding not to support approval based on the information provided.

It’s already well past the FDA’s original decision date for POSIMIR – the regulator was supposed to pass a final verdict on the drug by December 27, 2019.

But that had been delayed until the committee’s meeting, and the regulator has not yet set a new timeframe to close its review.

Durect said that in two completed adequate and well-controlled clinical trials, conducted in patients undergoing inguinal hernia repair and shoulder surgeries, respectively, Posimir demonstrated a significant decrease in pain and opioid consumption over the 0-72 hour period following surgery as compared to placebo.

The Californian biotech believes that these completed trials support the safety and efficacy of POSIMIR in post-operative pain and meet the requirements to be considered pivotal clinical trials.

Reuters reported that Abigail Shoben, a panel member from Ohio State University voted against the approval saying that the drug is “very slightly better than placebo” and as a result some “potentially minor safety concerns make the benefit to risk calculation challenging.”

Joseph O’Brien, chief executive officer of the National Scoliosis Foundation in Massachusetts, voted in favour of approval despite inconsistencies in the data.

“Despite all these concerns, at the end of the day, we do have a need for opioid-sparing medication,” he said.

In all, the company has completed 16 clinical trials of POSIMIR involving over 1,400 patients, over 850 of whom received POSIMIR, with the remainder in control groups.

POSIMIR has already been rejected once by the FDA in 2014 over safety concerns, and the PERSIST study that was designed to address these issues failed to meet its efficacy endpoint.

 

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