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In recent months, Vertex Pharmaceuticals announced positive results from studies of its experimental nonopioid painkiller. The excitement has added about $20 billion to the company’s market capitalization in recent months, with some Wall Street analysts describing the pain market as the next big opportunity after obesity. Yet the results, while encouraging, are far from being a home run. In two late-stage studies, the drug eased patients’ pain more than the placebo but failed to outperform Vicodin. In a bunion surgery trial, the opioid-based Vicodin outperformed Vertex’s drug on pain relief. The upshot is that while Vertex’s drug might not be a huge blockbuster, its success is likely to pave the way for better drugs down the line.

The Phase 2 trial announced Wednesday is one of a range of ongoing studies in various indications for Vertex’s medication, which analysts have said could bring in as much as $6 billion in sales for chronic pain. The company also plans to release results from three Phase 3 studies of the drug in acute pain in the first quarter of next year.

Based on the most recent data, about 100,000 people now die in the United States from drug overdoses over the course of a year, about half of them from synthetic opioids and primarily fentanyl [1,2]. That’s more than a 30 percent increase over 2019 levels, and a reminder that the exact causes of these tragic overdoses continue to evolve over time, including from changes in how people use drugs. Now, an NIH-funded study provides a detailed look at one shift in drug use: overdose deaths involving some combination of opioids and stimulant drugs, including cocaine and methamphetamine. These latest findings on the nation’s opioid epidemic, from a thorough analysis of death certificate data over a decade and up to the start of the pandemic, showed an alarming rise in overdose deaths from combined opioids and stimulants in all parts of the country. The data also reveal extremely troubling racial disparities. Opioid/stimulant deaths among Black Americans have risen at more than three times the rate seen among non-Hispanic white people, especially in Eastern states. In other parts of the country, there’s also been a disproportionate increase in these combination overdose deaths among Hispanic and Asian Americans.

The US Food and Drug Administration (FDA) has issued draft guidance to industry on the development of non-opioid analgesics for acute pain in an effort to spur the development of non-addictive pain treatments. The draft guidance, which is part of a larger Overdose Prevention Strategy from the Department of Health and Human Services (HHS), focuses on generating data for an indication of management of acute pain, labeling claims related to the elimination or reduction of opioid use, and the potential use of expedited programs for regulatory approval.

Fatal opioid overdoses are thought to be costing the U.S. economy $1 trillion each year, government officials have said. In a report published Tuesday by the bipartisan U.S. Commission on Combating Synthetic Opioid Trafficking, it was revealed that synthetic opioids — primarily fentanyl — were responsible for almost two in three reported drug overdose deaths in the U.S. in the year to June 2021.