Over one in three Americans experiences back pain annually, resulting in suffering and significant expense, including $87.6 billion in direct healthcare spending in 2013. [1,2]. Millions of back pain patients receive epidural steroid injections (ESIs) every year for back pain[3,4]. A herniated disc is the most common cause of this type of back pain. The injection is usually performed in a fluoroscopy suite to verify placement of the needle in the epidural tissue just outside the spinal cord. A significant portion of ESIs are repeat injections (a 2nd, 3rd, or 4th injection) over the first few months of treatment. Elimination of these repeat ESIs would drastically reduce the number of injection procedures that are performed, reduce procedure related infections and complications, and aid in the management of overall treatment costs. There is a documented risk of paralysis with transforaminal epidural injections of water insoluble generic steroids, which has been communicated by the FDA in 2014. Physicians routinely use water-soluble generic steroids to avoid this paralysis risk, but this form of steroid may be even shorter acting. Both water soluble and water-insoluble steroids for epidural injections are currently used off-label.
Our lead drug product candidate utilizes our patent protected sustained-release drug-delivery technology that is designed to meet the specific and unique needs of epidural administration and back pain.
- Sustained release profile targeted to provide pain relief for 60-90 days
- Potentially minimizes the need to perform repeat injections
- Designed to reduce risk of paralysis or severe adverse events that have been reported with some generic steroid suspensions
- Will utilize the same injection procedure as current therapies
- Utilizes a potent, well-established, anti-inflammatory steroid active ingredient
- In development for FDA approval to offer physicians an 'on-label' drug option
(1) Hoy, Damian, Christopher Bain, Gail Williams, Lyn March, Peter Brooks, Fiona Blyth, Anthony Woolf, Theo Vos, and Rachelle Buchbinder. 2012. “A Systematic Review of the Global Prevalence of Low Back Pain.” Arthritis and Rheumatism 64 (6): 2028–37. (2) Dieleman, J. L. et al. US Spending on Personal Health Care and Public Health, 1996-2013. JAMA 316, 2627–2646 (2016). (3) Manchikanti, Laxmaiah, Mark V. Boswell, Sukdeb Datta, Bert Fellows, Salahadin Abdi, Vijay Singh, Ramsin M. Benyamin, et al. 2009. “Comprehensive Review of Therapeutic Interventions in Managing Chronic Spinal Pain.” Pain Physician 12 (4): E123-198. (4) Abbott, Zach I., Kavita V. Nair, Richard R. Allen, and Venu R. Akuthota. 2012. “Utilization Characteristics of Spinal Interventions.” The Spine Journal: Official Journal of the North American Spine Society 12 (1): 35–43. (5) Racoosin, Judith A., Sally M. Seymour, Laurelle Cascio, and Rajdeep Gill. 2015. “Serious Neurologic Events after Epidural Glucocorticoid Injection — The FDA’s Risk Assessment.” New England Journal of Medicine