The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter—basically a rejection—to Austin, Texas-based Pain Therapeutics for Remoxy ER for pain.
The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter—basically a rejection—to Austin, Texas-based Pain Therapeutics for Remoxy ER for pain.
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. On June 26, 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.
The FDA argued that the benefits of the drug did not outweigh the risks.
“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.”
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 company says it “believes its program in Alzheimer’s disease has game-changing characteristics. PTI-125, the lead drug candidate, is a small molecule that has a unique mechanism of action for treating Alzheimer’s disease.”
The drug wrapped a successful Phase I clinical trial, which was funded by a peer-reviewed research grant from the National Institute of Health (NIH). It also has another asset, a blood test for Alzheimer’s called PTI-125DX, which the company claims can detect or confirm whether an individual has Alzheimer’s, even years before symptoms show. It is also substantially funded by the NIH.
“Alzheimer’s disease is a therapeutic indication with a profound need for new treatments,” Barbier said in a statement. “A reorganization of the company represents a natural and timely evolution of the strength of our program in Alzheimer’s disease.”
If their diagnostic test is effective, and there are even a few details about what biomarkers the assay tests for, it could be a very important product. Otherwise, a positive Phase I product for Alzheimer’s disease is a longshot. Literally hundreds of drugs for Alzheimer’s that were positive in Phase I have failed in Phase II and III. Still, it’s what the company has to offer. There is also no indication if or how many jobs will be cut in the restructuring.
Company stocks dropped 6.6 percent in premarket trading at the news. Overall, shares have dropped 39.8 percent this year, compared to the S&P 500 SPX, which has gained 6.2 percent.
As of June 30, at the company’s second-quarter financial report, Pain Therapeutics has cash and cash equivalents of $9.6 million. At that time, the company indicated it had enough cash to continue operations for the next 12 months.
