Pain Therapeutics refocuses on Alzheimer’s after FDA turns down abuse-deterrent opioid painkiller

pharmafile | August 7, 2018 | News story | Manufacturing and Production, Research and Development, Sales and Marketing FDA, Remoxy, opioid crisis, opioids, pain therapeutics, pharma 

The FDA has voted to reject Texas-based Pain Therapeutics’ abuse deterrent opioid painkiller Remoxy (oxycodone), leading the company to consider a strategic restructure and prompting a strong response from its President and CEO.

Remoxy is a long-acting formulation of Purdue’s infamous OxyContin but is designed in such a way that capsules resist most forms of tampering seen in abuse of other opioid medications. Pain Therapeutics had been seeking an approval for the drug in the treatment of patients who require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The decision to reject the therapy was made by an FDA advisory committee, which voted 14 to 3 to block the drug’s approval, arguing that the data submitted with the application was not enough to prove its benefits outweighed its risks. The news hit the company’s shares hard, sending them plunging by 35%.

“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.”

In the same release detailing the news, the company also announced it would be reorganising its operations to focus instead on its developing therapies in Alzheimer’s disease, particularly its lead candidate which tackles the condition with a unique mechanism of action.

“Alzheimer’s disease is a therapeutic indication with a profound need for new treatments,” Barbier added. “A reorganisation of the Company represents a natural and timely evolution of the strength of our programme in Alzheimer’s disease.”

Matt Fellows

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