Experts say that the best way to defeat an epidemic is to reduce exposure. In this case, the challenge is to reduce opioid exposure without compromising patient care. By controlling exposure, our technology could (i) prevent fatal overdoses and save thousands of lives each year; (ii) preclude the most prevalent oral route of misuse and abuse of prescription opioids[1], and disrupt the heartbreaking and often lethal progression to fentanyl and heroin use and addiction; and (iii) provide safe, highly-effective pain relief to patients.

Furthermore, multiple efforts to identify safe and effective non-opioid-based pain therapies have failed. Some alternatives that made it to market are not nearly as effective as opioids, and, sadly, are fraught with significant safety risks (e.g., NSAIDS with increased cardiovascular risks and acetaminophen with hepatic toxicity). While efforts to discover novel, non-opioid pain therapies continue, according to experts it will be at least ten years before one makes it to market, and their ability to effectively treat a wide range of pain states remains questionable. In the meantime, opioid agonists are expected to remain the dominant pain therapy due to their unmatched efficacy and safety when taken as prescribed.

The entwined national epidemics – prescription drug abuse and overdose, and undertreated pain – have given rise to the need for pain therapies that are less likely to be abused. President Trump has reiterated his position that safer opioids will play a key role in addressing the opioid crisis. He pledged to expand access to abuse-deterrent (AD) opioids to fight these epidemics. The FDA has also indicated that it will use its authority to expand the use of abuse-deterrent opioids, including the removal of currently marketed opioids for safety reasons. This could represent a unique opportunity to rapidly grow sales in a market with 150M+ annual prescriptions.

A balanced solution that addresses both (i) individual patient's needs for effective pain relief, and (ii) the devastating national opioid epidemic is needed.

1 Maciej Gasior, Mary Bond & Richard Malamut (2016) Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations, Postgraduate Medicine, 128:1, 85-96, DOI: 10.1080/00325481.2016.1120642. (