Pharma Forum Dialogues

Pain Drug Development to Address High Unmet Need

Posted by New York Pharma Forum Inc. on Jun 24, 2014 12:19:00 PM

By Amit Dhawan, MD, and Michael Fronstin, Kantar Health

pain drug development

Pain is a large and growing market globally, affecting more than 1 billion people worldwide. It is a high-prevalence, low-diagnosis market and often results in extremely high unmet needs. As anyone who experiences pain, either chronically or acutely, can tell you, it is incredibly difficult to treat because everybody experiences it differently, and the many different types of pain add another layer of complexity.

In an effort to improve patients’ outcomes, more than 2,500 compounds are in development for pain indications; however, most of these compounds represent reformulations of existing molecules. To address the issue of prescription pain medicine abuse, a substantial amount of activity also is focused on creating abuse-deterrent formulations, again utilizing existing molecules, typically opiates.

Two of the most promising mechanisms of action in development in the pain market are:

  • CGRP (calcitonin gene-related peptide), which is considered as a possible biomarker for migraines and a key target for future migraine drugs. Of the five CGRP products in development, only one is an oral formulation. The remaining will require injection or infusion.
  • Anti-NGF (anti-nerve growth factor), which is a key target for musculoskeletal pain. The anti-NGF products in development will require injection (likely self-injection or infusion).
While these new mechanisms of action are attacking pain relief in a more targeted way,they are, for the most part, large molecules requiring a non-oral route of administration, which may pose challenges for some patients.
pain drug development

Michael Fronstin, General Manager, Health Outcomes Group, Kantar Health

 Serious side-effect issues were identified during clinical trials for both pain targets, and multiple companies are working on approaches that overcome the high safety hurdle to continue development of drugs for these potentially high-reward targets. Recently, Pfizer and Eli Lilly announced a partnership in October 2013 to develop tanezumab, an anti-NGF, in Phase III once Pfizer submits the required nonclinical data to remove the FDA partial clinical hold on the program. While several new promising mechanisms of action are in development, based on their stage of development, most will not enter the market until 2015 or later.



pain drug development

Amit Dhawan, M.D., M.B.A., M.H.A., Consultant/Medical Director of the Clinical & Scientific Assessment Group at Kantar Health

 

Consistent with demographic trends and high unmet need, diabetic  neuropathy, osteoarthritis and postherpetic neuralgia are indications  with a large number of compounds in development. More than 25  unique compounds are in Phase II or later development targeting these areas of high unmet need. Although products are on the  market already to treat these types of pain, patient satisfaction levels are relatively low and efficacy is modest with these compounds.

Interstitial cystitis/chronic bladder pain is an emerging area of interest for drug development as the condition is gaining greater awareness among physicians and patients.

Due to the high cost of pivotal Phase III trials, a significant percentage of novel pain compounds await partnering after having been developed until mid-Phase II to demonstrate clinical proof of concept. Over the past two years, the migraine market has had the most partnering activity. Other areas with significant activity include neuropathic and cancer pain.

Research agendas in pain are increasingly focusing on genetics and the molecular levels of pain stimuli. Although well behind therapeutic areas such as oncology, the future of pain drug development is anticipated to be targeted therapy.

 

Amit Dhawan, M.D., M.B.A., M.H.A., is a Consultant / Medical Director in Kantar Health's Clinical & Scientific Assessment group.  Dr. Dhawan has expertise in clinical medicine, new product analysis, epidemiology, and market trend forecasting. Dr. Dhawan holds an M.D. and an M.B.A. from the University of Missouri-Kansas City, and an M.H.A. from the Washington University School of Medicine.

Michael Fronstin is General Manager of the Health Outcomes group at Kantar Health. Mr. Fronstin is responsible for the global commercial strategy, operations and new product implementation of the Health Outcomes Practice including the National Health and Wellness Survey. In addition to the US market, he is responsible  for ensuring the commercialization and  exportation of the National Health and Wellness Survey into Asia, Europe (including Russia) and Brazil. Mr. Fronstin has an MBA in Health Care Administration from the University of Miami,  Florida, and a BA from the University of Albany, New York.

 

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