The NIH Wednesday announced the launch of the HEAL (Helping to end addiction long-term) Initiative, a trans-agency effort to speed scientific solutions to stem the national opioid epidemic. As part of the initiative, the NIH is nearly doubling its funding for research on opioid misuse/addiction and pain from about $600 million in fiscal 2016 to $1.1 billion this year. The HEAL Initiative will bolster NIH research to prevent addiction through enhanced pain management and to improve treatments for opioid misuse disorder and addiction. The research will seek to to identify biomarkers that might predict which patients are more likely to transition from acute to chronic pain; identify potential new targets to treat chronic pain and objective biomarkers to predict who would respond to a specific treatment; advance understanding of the genetic and social factors that put patients at risk for opioid misuse and addiction; and define and support best practices for pain management using nondrug and integrated therapies for specific conditions. In addition, the NIH plans to pursue public-private partnerships to develop new nonaddictive pain drugs by sharing data on past and present research projects, and matching researchers with potentially promising but abandoned compounds to explore their effectiveness in treating pain. It also will build a clinical trials network to allow the simultaneous effectiveness testing of multiple new and repurposed compounds. On the addiction treatment side, the agency will fund research to expand treatment options and overdose reversal drugs, and evaluate treatments and the long-term consequences of neonatal opioid withdrawal syndrome. It also will work with federal and state partners on pilot demonstration projects to test the integration of multiple addiction prevention and treatment options.
The FDA finalized its guidance Liposome Drug Products: Chemistry, Manufacturing and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation. The guidance focuses on the unique technical aspects of liposome drug products and discusses what types of information sponsors should submit in a new drug application or abbreviated new drug application for a liposome drug. Although the guidance doesn't provide recommendations specific to liposome products to be marketed under biologics license applications (BLAs), many of its scientific principles may apply to BLAs, the FDA said.