The National Institutes of Health (NIH) has reissued a Funding Opportunity Announcement (FOA) under the HEAL Initiative (Helping to End Addiction Long-term). The goal is to develop therapies and technologies for enhanced pain management through the Small Business Innovation Research (SBIR) program. This FOA, titled "Development of Therapies and Technologies Directed at Enhanced Pain Management," invites small businesses to submit innovative projects aimed at improving non-addictive treatments for pain, with a focus on pain measurement, management strategies, and new pain therapies.

The FOA seeks to address the critical need for effective, non-addictive alternatives to opioid-based pain treatments, especially in the context of the ongoing opioid crisis in the United States. Pain is a complex condition affecting more than 25 million Americans, and this has led to a reliance on opioid treatments, which often fail to provide long-term functional improvement and carry risks of addiction and overdose. The HEAL Initiative is a cross-agency effort, and this funding opportunity is intended to accelerate scientific solutions by supporting innovative treatments that better address pain without contributing to the addiction problem.

Eligible applications should focus on developing technologies for understanding pain biology, creating new pain therapies, and advancing tools for pain management. These might include novel screening tools, objective pain measurement methods, non-addictive analgesic treatments (small molecules, biologicals, devices), and pain management strategies for both acute and chronic pain conditions. This opportunity excludes projects related to opioid mechanisms or methods aimed at tracking or reducing opioid use, as well as NIH-defined clinical trials.

NIH anticipates committing up to $8 million annually, funding approximately 5-15 awards depending on the type of project (Phase I or II). Phase I awards may not exceed $275,766, while Phase II awards can go up to $1,838,436. Projects may last up to two years for Phase I and up to three years for Phase II. Small U.S. businesses are eligible to apply, and each business must have no more than 500 employees, meet specific ownership criteria, and demonstrate potential for commercializing the developed technologies.

Applications are accepted multiple times a year, with submission deadlines in January, April, and September, up to 2025. A letter of intent is optional but encouraged, and applications should be submitted through NIH’s ASSIST system or Grants.gov. Successful applications will be those that present a clear commercialization plan, outline realistic milestones, and address regulatory pathways for bringing the innovations to market.

Projects will be evaluated on significance, innovation, approach, environment, and investigator qualifications, with special attention to commercial potential, market competition, and customer needs. NIH is particularly interested in solutions that are likely to progress through the regulatory approval process and meet the unmet needs of the market, especially in addressing the opioid crisis.

This initiative represents a substantial opportunity for small businesses to contribute to addressing one of the most pressing public health crises by developing next-generation solutions for pain management that avoid the risks associated with opioid use.