With little surprise, Pain Therapeutics has been hit with a complete response letter from the FDA for Remoxy ER, its extended-release, capsule gel form of the opioid oxycodone.

This letter came a month after the company saw an FDA adcomm vote against the medicine, and after years of it not being good enough for approval, leaving this rejection as an inevitability. 

According to FDA: "The data submitted in [the] NDA do not support the conclusion that the benefits of [REMOXY] Extended-Release Capsules outweigh the risks," the company said in a brief update.

"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, President & CEO. 

"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 judgement call that is vague in nature but conclusive in its damaging effects."

There’s a long history here, and a long history of rejection. The Austin, Texas-based company licensed Remoxy ER from Durect back in 2002. It is designed to manage pain severe enough to require "daily, around-the-clock, long-term opioid treatment" that isn’t adequately controlled with other options.

And its "thick, sticky, high viscosity, hydrophobic" gel formulation is meant to prevent abuse—it’s designed to stop would-be abusers from dividing it into smaller pieces for snorting, or dissolving it for injection.

Pain Therapeutics filed its first NDA for Remoxy a decade ago, receiving its first complete response letter from the FDA in December the same year. A few months later, Pain Therapeutics inked a deal around the asset with King Pharmaceutical, which filed a resubmission in December 2010. Pfizer ended up with Remoxy the following February, when it closed its acquisition of King Pharma.

The FDA rejected Remoxy a second time in June 2011—at the time, Pfizer said it would work to fix the issues highlighted in the CRL. But it ended up abandoning ship in 2014, handing the rights to Remoxy back to Pain Therapeutics. The FDA sent yet another CRL for Remoxy in 2016, saying the "NDA cannot be approved in its present form and specifies additional actions and data that are needed for drug approval."

Now, cuts and changes are on the cards, as it kick-starts a "strategic reorganization" to focus on its drug and diagnostic assets in Alzheimer’s disease (AD). 

"Full details of the company’s reorganization plan, including specific milestones and measures of clinical progress, will be shared with the public via conference call within weeks, after the reorganization is finalized," it said. So, no word on just how many may be cut as yet.

AD is, however, also a highly risky proposition for big and small biopharmas alike, with a slew of failures over the past 15 years haunting the research community.

The company was down around 20% in premarket trading this morning.

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