- The Food and Drug Administration has once again rejected Pain Therapeutics' abuse-deterrent version of oxycodone, prompting the company to shift resources away from pain and toward Alzheimer's disease.
- Regulators have now issued four Complete Response Letters (CRLs) for Remoxy since December 2008. The letters cited a variety of problems with the drug, including inconsistent release performance during in vitro testing and the need for more data about its abuse-deterrent properties.
- It looks as though this latest setback is the final straw for Remoxy. On Monday, Pain announced a strategic reorganization that prioritizes PTI-125 and PTI-125DX, an investigational treatment and blood test for Alzheimer's. More details about the reorganization will become available in the coming weeks, the company said.
Abuse-deterrent opioids, formulated to make it harder for patients to snort, inject or otherwise misuse them, have become a favorable option against the backdrop of a national opioid crisis. Yet they still constitute a very small portion of the overall opioid painkiller market.
There, generic opioids remain dominant because of their analgesic effects and low price tags.
"From a payer's perspective, you have a perfectly effective medicine — existing opioids — that are generic, that are very inexpensive relative to anything else, and they work," Dan Cohen, head of government and public relations for pain-focused drugmaker KemPharm, told BioPharma Dive back in March.
Additionally, many companies have had a difficult time proving to regulators their drugs are indeed abuse-deterrent. For instance, KemPharma didn't secure an abuse-deterrent label for its recently greenlighted drug for acute pain management, Apadaz (benzhydrocodone and acetaminophen). Pain Therapeutics also ran into trouble on this front, as regulators continued to question whether Remoxy worked as intended.
The FDA wrote in its latest CRL that Remoxy's risk-benefit profile didn't warrant an approval, according to an Aug. 6 statement from Pain, a point with which the Texas-based pharma clearly disagreed.
"This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction. 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," company CEO Remi Barbier said in the statement.
To that point, Pain disclosed early this year positive results from a human abuse potential study that showed non-dependent, recreational opioid users had significantly lower abuse potential when taking nasal Remoxy versus immediate-release oxycodone.
Still, an FDA advisory committee six months later voted 14-3 against the approval of Remoxy extended release.
"We relied on the criteria of a fair, neutral and impartial regulatory review, as any sponsor would," Barbier added. "Instead, I believe Remoxy received an ideological judgment call that is vague in nature but conclusive in its damaging effects."
In lieu of the setbacks, Pain is focusing attention on PTI-125 and PTI-125DX, with more information about milestones and clinical plans expected after the reorganization finalizes. As of June 30, the company had $9.83 million in total assets, nearly all of which was cash and cash equivalents.
Pain stock opened at $2.18 per share Monday, down about 10% from its value at market's close on Friday. Shares continued to sink, however, trading at $1.45 apiece later in the morning.