Summary: The study revealed that 27.8% of pain medications with a high potential for abuse made it throughout the development process, compared to only 4.7% of drugs with a lower abuse potential.
source: American Society of Anesthesiologists
The authors of a study published in Anesthesia.
“The opioid crisis has highlighted the need for new therapies with low abuse potential to treat chronic pain,” they said.
“While pharmaceutical companies recognize this need, due to the subjective nature of pain… Conducting clinical trials for approval of new drugs is a long and expensive proposition.”
According to the authors, a better understanding of the potential for successful development of new pain medications would reduce some of the investment risks.
In the retrospective study, Dermot P. Maher, MD, MS, MHS, associate professor, Johns Hopkins University School of Medicine, Baltimore, and colleagues in financial engineering at the MIT School of Management analyzed 469 pain pharmaceutical development programs that include 399 unique active drug ingredients. between 2000 and 2020.
They used publicly available clinical trial metadata from databases provided by Informa Pharma Intelligence to determine the odds for success, duration, and survival of pain reliever development programs.
The study found that 27.8% of drugs with a high abuse potential made it through all stages of the development process, compared to only 4.7% of new drugs with a low abuse potential.
Although the number of drugs with high abuse potential being developed has declined since the height of the opioid epidemic in 2010, they are more likely to complete development successfully and receive regulatory approval than drugs with low abuse potential.
“The greatest potential for successful development could represent a more comprehensive biological understanding of pain signaling pathways targeted by drugs with high abuse potential compared to novel mechanisms provided by alternative drugs with low abuse potential,” they said.
“The opioid crisis has been a wake-up call for medicine as a whole,” said Dr. Maher.
On the other hand, we’ve had patients simply request that their pain be addressed. On the other hand, clinicians had so little in their pharmaceutical kit that it was either remarkably effective, non-addictive or lacking significant side effects. “
He noted that it is important to realize that it is possible to successfully develop pain relievers. “We can increase our understanding of the mechanisms of pain and target the development of new pain therapies to meet this unmet medical need,” said Dr. Maher.
In an accompanying editorial, Michael S. Sinha, MD, JD, MPH, and Kelly K. Deanne Gillespie, RN, JD, PhD, supported Dr. Maher for further development of pain medications with better safety profiles. They said federally funded research should be conducted to learn more about the biology and mechanisms of pain.
“The National Institutes of Health (NIH) and research sponsors should allocate funding to develop safer analgesics and non-drug pain management strategies,” they assert.
“Expanding support for the National Institutes of Health’s Helping End Addiction Long-Term Initiative (HEAL) is one way to achieve this goal.”
They also contend that changes are warranted “in public and private funding models to encourage and reward time-consuming, multidisciplinary, multimodal pain treatment programs—programs highly effective in promoting well-being and function but currently rare in a system that continues to reward highly fragmented care and intervention.”
There is a need for investment in cross-training for providers of pain medicine, treatment of substance use disorders, as well as trauma-informed care. Innovative, non-invasive biotechnology also shows promise.”
To turn the tide of pain management research, they concluded, “Coordinated action by key stakeholders from the public and private sectors across the areas of multimodal therapy is the best way forward.”
Learn more about National Institutes of Health Heal . InitiativeA cross-agency effort to combat the opioid crisis by accelerating scientific solutions.
About this pharmacology and addiction research news
author: Theresa Hill
source: American Society of Anesthesiologists
Contact: Theresa Hill – American Society of Anesthesiologists
picture: The image is in the public domain
original search: open access.
“Estimates of the prospects for successful development of pain medications: an analysis of clinical pharmaceutical development programs from 2000 to 2020By Dermot B Maher et al. Anesthesia
Estimates of the prospects for successful development of pain medications: an analysis of clinical pharmaceutical development programs from 2000 to 2020
The authors estimate the potential for successful development and duration of clinical trials of drugs for the treatment of neuropathic pain and nociceptors. The authors also consider the effect of the potential for drug misuse on these variables.
This study uses the Citeline database to calculate the probabilities of success, duration, and survival for pain reliever development programs between January 1, 2000 and June 30, 2020, subject to stage and type of pain (nociceptive). against. neuropathy), the possibility of drug abuse.
The overall probability of successful development of all phase I pain medications through approval is 10.4% (standard error, 1.5%). Medicines used to treat nociceptive pain and neuropathic pain have a probability of successful development of 13.3% (standard error, 2.3%) and 7.1% (standard error, 1.9%), respectively. The probability of successful development of drugs with high abuse potential and low abuse potential are 27.8% (standard error 4.6%) and 4.7% (standard error 1.2%), respectively. The most common period of tapering is between stage 3 and approval.
Our data suggest that unique features of pain medications, such as their potential for abuse and intended pathology, can influence the likelihood of successful development and the duration of development.