The ongoing opioid crisis in the US continues to hit devastating record numbers of deaths. Last year, over 110,000 people died because of opioid overdose, mostly due to the use of fentanyl, a powerful opioid painkiller. While some pharma companies are in the midst of lawsuits and settlements, others are trying to find a way to combat the ongoing epidemic.

Ketan Mehta, CEO and founder of Tris Pharma, says that the pharma industry needs to find a solution to the opioid epidemic in the US. The company is investigating cebranopadol, a pain killer with potentially fewer addictive properties. “We hope to give patients an option without creating addiction and other epidemic issues that we are facing right now,” he adds.

Last December, Tris announced positive top-line results from a Phase I human abuse potential study in patients who are nondependent recreational opioid users. The data revealed that oral administration of cebranopadol has significantly less potential for abuse compared to tramadol and oxycodone.

Now, the company is gearing up for pivotal Phase III trials in multiple pain states, as well as additional human abuse potential studies to investigate the non-oral administration of cebranopadol.

Cebranopadol is a novel, dual nociceptin/orphanin FQ peptide (NOP) receptor and μ-opioid peptide (MOP) receptor agonist. “What makes cebranopadol so unique is that the NOP-1 receptor adds its own analgesia, but more importantly, it has a regulatory effect on the opiate receptor that makes the drug less abusable, addictive and prone to overdose,” explains James Hackworth, PhD, president of the brand division at Tris.

Registrational trials in multiple pain indications

Tris is currently in discussion with the FDA to design late-stage trials investigating the drug in multiple pain states. Hackworth says that the initial indication will be acute pain because there is a massive need as people get prescribed opioids after surgeries or injuries. “Those are the patients that are first exposed to opioids and are most at risk for overdosing or becoming [users],” he adds. Clinical Trials Arena previously reported on the unmet need of substance use disorder therapies.

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While the exact clinical trial design is yet to be determined, Tris is planning to recruit several hundred people. Depending on the speed of the recruitment, the trial is likely to run for around four to six months, with an estimated start date by the end of H1 2023.

The company is also planning to conduct multiple trials investigating the drug in people with chronic pain. Clinical Trials Arena previously reported on the challenges of measuring pain in clinical trials. All of the late-stage trials will take place in the US, however Mehta says that at least one trial site outside of the US would be ideal.     

Additional trials for differentiation

Alongside Phase III trials, Tris is planning to gather as much information about the drug as possible. Currently, the company is conducting a trial looking at very high doses of cebranopadol compared to opioids and its effects on respiratory depression, which is commonly caused by opioid overdose. “We are confident that the outcome will show a significant differentiation,” Hackworth says.

Also, people tend to manipulate opioids and use the drugs by ingesting, snorting, or injecting them. So later this year, Tris will be conducting additional human abuse potential studies looking at non-oral administrations, such as powder and IV formulations, of cebranopadol. The trial designs will be similar to the previous human abuse potential trial (NCT05256108) which used Drug Liking Visual Analogue Scale (VAS) as a primary endpoint in recreational opioid users. These trials will be conducted in the US. “Unfortunately, the US is really the place where you’ll find large numbers of this population,” Hackworth notes.

Indeed, many Americans are struggling with the available pain solutions. Hackworth explains that many patients who are in severe pain require options that no non-opioid can currently fulfil. “We believe that this drug has a chance to transform pain care,” he adds. As previously reported on Clinical Trials Arena, pain as an indication have the highest number of upcoming trials in 2023.