The Galien Forum USA 2018

Novel Approaches to Combatting Opioid Addiction

Chronic pain is a prevalent but frequently under‐reported condition affecting some 75 million Americans each year, more than the incidence of diabetes, heart disease and cancer combined. It is the leading cause of long‐term disability in the US and accounts for a major share of the physician visits, hospital admissions, prescription drug Rx and other expenditures that drive up overall health costs. The WHO estimates that 10 per cent of the world’s population lives with chronic pain, an incidence that is forecast to rise rapidly as more emerging market countries make the epidemiologic transition from communicable to non‐communicable diseases like arthritis and cancer, where effective pain management is a critical factor in diagnosis, treatment and recovery.

More important, the overuse of many opiate‐based pain medications approved in the last 30 years has produced a highly visible crisis in public health. Addictive dependence on opioid formulations, bolstered by fast‐acting companion narcotic highs like heroin, has led to a sharp spike in drug overdose. The US Center for Disease Control and Prevention (CDC) registered a 30 per cent increase in the number of emergency room admissions linked to opioid abuse over the past two years. Over 66,000 fatalities were attributed to opioid abuse in the US in 2017, making it the leading cause of accidental death in the adult population. Productivity and economic losses associated with opioid abuse have been estimated at $80 billion annually, exceeding those of the HIV epidemic prior to the onset of protease inhibitor drugs in the mid‐1990s. The potential value of effective abuse deterrent pain formulations is easy to register, from both an economic and social policy perspective.

Research interest in finding alternatives to opioid‐based drugs has increased in line with the mounting human toll from abuse. But developing new medicines that relieve pain without dependence has proven far more difficult than expected. Since 2013, 10 such “abuse deterrent” drugs have won approval from the FDA. Improvements in standard of care have been applicable mainly to intranasal or intravenous administration, where the incidence of abuse is lower. Other new innovations in various stages of clinical and pre‐clinical testing are gene‐based therapies, such as calcitonin gene‐related peptide receptor antagonists; and nanoscale and microparticle delivery technologies that target powerful drug payloads at the nerve cells responsible for the inflammation that causes pain.

In addition, companies with development programs on abuse deterrent formulations are encountering stiff resistance from payers on market access and reimbursement. Some innovative producers are considering partnerships with generic companies as a strategy response to pricing concerns. And some payers question whether the ADFs deliver sufficient value for money, basically asking innovative companies to come up with a cure for pain, not just another palliative.

In this Forum panel, chaired by Robert Langer, MD, David H. Koch Institute Professor at MIT and member of the Prix Galien USA Awards Committee, participants will discuss the state of research in next‐generation pain medications and drug delivery technologies that counter respiratory depression and possess measurable abuse deterrent properties – the two aspects of opioid‐based therapy that characterize the unsatisfactory current standard of care. The group will also share recent progress in understanding the foundational biology of pain as a diverse set of conditions – somatic, inflammatory, and neuropathic – that together defy the search for a single, seamless integrated solution.