About SP-102 (SEMDEXA™)
- Innovative, potentially first and only FDA-approved non-opioid chronic pain treatment
- Large, established, yet underserved commercial opportunity
- Large growing unsatisfied market and current therapeutics provide limited pain relief, serious side effects
- Low technical and reimbursement risks and rapid development program
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COMPLETED PHASE 3 TRIAL IN 2024.
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Results from a Pivotal Phase 3, DB, R, Placebo-controlled, Multicenter Trial of SP-102, a Novel Dexamethasone Injectable Formulation, for the Treatment of Patients with Lumbosacral Radiculopathy (Sciatica) are here:
SP-102 (SEMDEXA ™) Potential
SP-102 has the potential to be the first non-opioid epidural product approved to treat a common condition, lumbosacral radicular pain, which could be an important alternative to compounded and off-label used steroids.
Opioid prescriptions account for up to 60 percent of the chronic pain market and carry a well-known risk of abuse and misuse, underscoring the need for alternative pain therapies without the medical and societal challenges.*
Use of the opioids and other drugs associated with safety risks and addictive potential. Opioids are commonly used for lumbosacral radicular pain and if taken with benzodiazepines can be extremely dangerous and possible lead to overdose/death. Reducing reliance on narcotics and providing alternative FDA approved treatment may address an important public safety concern and contribute to reduction of opioid use.
There are currently no steroids approved for epidural use, and compounded steroid preparations have been associated with outbreaks of fungal meningitis, sometimes with fatal outcomes. Other medications sometimes used for epidural injections (e.g.: local anesthetics) do not treat the underlying inflammation.
* Opioids for Back Pain Patients – Primary Care Prescribing Patterns and Use of Services (National Institutes of Health 2011)
