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iStock, Besiki Kavtaradze The Supreme Court last year blocked a previous settlement proposal from Purdue, arguing that the plan would afford the Sackler family too much protection. Purdue Pharma on Wednesday filed another Chapter 11 Reorganization Plan with an eye toward delivering more than $7.4 billion in opioid settlement payments. Last year, the Supreme Court in a slim 5–4 vote blocked Purdue’s previous attempt to claim bankruptcy. The pharma’s prior plan, according to the justices, would have seen the Sacklers hand over up to $6 billion, but would also protect the family from future litigation. This would afford the Sacklers too much protection from fallout in the company’s role in the U.S. opioid epidemic, according to the justices, who noted that such safeguards are not backed by federal bankruptcy laws. Under Wednesday’s new reorganization proposal, the Sacklers would contribute between $6.5 billion and $7 billion to the total settlement value, of which $1.5 billion would be disbursed upfront while the remaining balance would be payable over the next 15 years. In turn, a public benefit company would deliver the money to creditors “to compensate victims and abate the opioid crisis,” according to Purdue’s Wednesday release. Of note, the new plan “does not contain non-consensual third-party releases.” Creditors will instead have to opt in to the plan to receive payments. Otherwise, creditors that choose to not participate in the program will retain their right to sue the Sacklers. Purdue’s new plan is set to come before a bankruptcy court in May 2025 for confirmation or amendments. If approved, Purdue will then put the plan up for an internal vote before it can be implemented. Purdue, once owned by the Sackler family, is widely considered the chief architect of the opioid crisis in the U.S. Many allege that its synthetic opioid painkiller Oxycontin was marketed aggressively —with its side effects and addictive nature downplayed—leading to the wave of overdoses across the country. The pharma in November 2020 pleaded guilty to criminal charges related to the epidemic, in a plea deal that included accepting responsibility for it, but the Sacklers themselves have since tried to evade accountability. In December that same year, the family apologized to victims in a virtual appearance at a hearing but stopped short of admitting their own personal role in the crisis. Purdue’s proposal comes as change may be on the horizon in the pain space. In January, the FDA handed a landmark approval to Vertex Pharmaceuticals’ Journavx, the first non-opioid painkiller in more than 20 years. Several other biopharma players are following in Vertex’s footsteps, advancing their own non-addictive analgesics. One of these is Latigo Bio, which is running a Phase II trial for its sodium channel blocker LTG-001. Lexicon Pharmaceuticals, meanwhile, is advancing the small-molecule painkiller pilavapadin, which targets the AAK1 protein, a mechanism that has been shown to alleviate neuropathic pain. Pilavapadin is in Phase IIb development for diabetic peripheral neuropathic pain, topline results from which showed the candidate could meaningfully reduce pain through 8 weeks.

Tris Pharma has been touting cebranopadol as offering a potential solution to the opioid crisis.\n Tris Pharma’s opioid alternative has scored a third win in a trio of clinical trials, providing the biotech with the data needed to take the pain relief drug to the FDA this year.The latest readout saw cebranopadol, a dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor agonist, tested in a phase 3 trial of patients who have undergone toe surgery.The study achieved its primary endpoint of showing a statistically significant reduction in pain intensity measured each hour over 48 hours compared to placebo. Specifically, a once-daily 400-µg dose of cebranopadol resulted in a mean 56.1-point reduction in this pain measurement compared to placebo, giving a p-value of less than 0.001.A total of 57.5% of patients receiving cebranopadol didn’t require an additional “rescue medication” of a common analgesic, such as ibuprofen, over seven days compared to 28.4% of those on placebo, the biotech noted.A separate arm of the study involved patients receiving the common opioid oxycodone four times a day. The mean pain relief experienced by these patients was also less than the cebranopadol cohort, the company said.Tris’ drug also showed a favorable safety profile, with nausea being the most common adverse event and no serious adverse events reported in the trial. Today’s readout rounds off a trio of clinical proof points for cebranopadol this year, which Tris has been touting as offering a potential solution to the opioid crisis. January saw the biotech demonstrate a statistically significant reduction in pain intensity in patients who had undergone cosmetic surgery on their abdomen. Days later, the company pointed to data from a phase 1 trial of a crushed, nasal insufflation dose of cebranopadol to show that it was less likely to be abused than oxycodone.“With our phase 3 program for cebranopadol in the treatment of moderate-to-severe acute pain complete, we now have a comprehensive data package that will be submitted to the FDA as the basis for potential approval,” Tris’ CEO Ketan Mehta said in the March 6 release. “If approved, cebranopadol has the potential to redefine the standard of care for acute pain management, offering a first-in-kind treatment option for patients in need.”At the J.P. Morgan Healthcare Conference in San Francisco in January, Tris Chief Business Officer James Hackworth, Ph.D., told Fierce that the biotech believes cebranopadol’s mechanism is “unique.”While cebranopadol stimulates the MOP receptor in the same way that opioids do, its ability to also stimulate the NOP receptor avoids the other effects that have contributed to opioids’ addictiveness, he explained.Tris isn\'t the only company looking for a new way to treat pain after the the FDA recently approved Vertex Pharmaceuticals’ NaV1.8 pain signal inhibitor Journavx. But Hackworth told Fierce at JPM that he sees Vertex’s offering as “more complementary” than competitive to cebranopadol.