The persistent challenge of opioid addiction, involving substances such as heroin, fentanyl, and oxycodone, remains a significant public health concern both in the United States and globally.
A key obstacle in addressing this addiction crisis is the management of withdrawal symptoms. The symptoms include intensified pain, nausea, excessive sweating, and mental health issues like depression and anxiety.
Often resembling a severe flu, these symptoms can be life-threatening, and the fear of experiencing these symptoms contributes to opioid users’ reluctance to stop taking their drug.
The interest of NIDA in PN6047, prompted by the drug's very positive effects on neuropathic pain, reflects the ongoing efforts of NIDA to find effective treatments for opioid withdrawal.
This interest has fostered a NIDA-funded collaboration between PharmNovo and Profs Amynah Pradhan (Washington University) and Emily Jutkiewicz (University of Michigan).
The collaborative project focuses on testing PN6047 in animal models of opioid withdrawal syndrome and exploring its differences from conventional opioids.
Per von Mentzer, CEO of PharmNovo, commented on the development, stating: “PN6047 is completely different from traditional opioid drugs. As a highly selective and biased DORA, it offers a new perspective on pain management and opioid withdrawal treatment."
"We are encouraged by the interest from NIDA, which not only recognises the potential of PN6047 to provide relief but also validates its no abuse potential.”
Understanding PN6047 and its role in opioid withdrawal care PN6047 is a highly selective Delta Opioid Receptor Agonist (DORA) that offers a new approach to managing neuropathic pain and opioid withdrawal.
Unlike traditional opioids, PN6047 selectively targets the delta opioid receptor, avoiding the mu-opioid receptor often associated with high addiction risks and severe side-effects.
This selectivity, along with biased signalling, has shown in animal models that PN6047 can effectively alleviate neuropathic pain without the typical negative mu-opioid effects, including abuse potential.
Comprehensive data from preclinical studies suggest that PN6047 has no abuse potential. This is further supported by Phase I clinical data, where no side effects indicating abuse potential have been observed.
Ongoing studies in the NIDA project have also demonstrated the candidate’s effectiveness in pain relief during intensified pain due to opioid withdrawal and its potential to alleviate symptoms of depression and anxiety.
Phase I study data of PN6047 have shown promising results regarding safety and tolerability, paving the way for additional studies of PN6047 in opioid withdrawal syndrome, with a potential for support from NIDA. PharmNovo plans for clinical Phase II trials targeting neuropathic pain, scheduled to begin in 2024.