On Track to Potentially Become The First and Only Non-opioid
Product Approved for Treating Sciatica
- SP-102 (SEMDEXA™) is a preservative free, surfactant free, suspension free and particulate free viscous gel injection of dexamethasone sodium phosphate equivalent to 10mg dexamethasone at 5mg/mL, 2mL deliverable volume for sciatica (lumbosacral radicular pain) treatment.
- 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
SP-102 (SEMDEXA™) Product Formulation
We are developing SP-102 injection to address problems associated with currently available corticosteroid products that are used in practice but not approved for epidural injection or the treatment of lumbosacral radicular pain (LRP) also called “sciatica”. SP-102 is a Phase 3 sterile dexamethasone sodium phosphate viscous gel product of 10 mg dexamethasone at a 5 mg/mL concentration in a pre-filled glass syringe for delivery via an epidural injection.
SP-102 allows for the use of the potent dexamethasone and provides for longer residency time at the site of injection through the use of sodium hyaloronate, which is a viscous gel excipeitn in lieu of particulates. The product is also formulated without the use of preservatives and packaged in a pre-filled syringe, so as to confer greater physician convenience.
SP-102 (SEMDEXA™) Potential
SP-102 (SEMDEXA™) has the potential to be the first non-opioid epidural injection approved in the United States to treat a common condition, lumbosacral radicular pain, which could be an important alternative to compounded and off-label used steroid injections. It is potentially the first non-opioid novel injectable corticosteroid viscous gel formulation for patients with moderate to severe chronic radicular pain/sciatica, containing no preservatives, surfactants, solvents, or particulates.
Completed Pivotal Phase 3 C.L.E.A.R. Trial
- Results from a Pivotal Phase 3, DB, R, Placebo-controlled, Multicenter Trial of SP-102 (SEMDEXA™), a Novel Dexamethasone Sodium Phosphate Viscous Gel Injectable Formulation containing equivalent to 10 mg dexamethasone at 5 mg/mL concentration with 2 mL deliverable volume, for the Treatment of Patients with Lumbosacral Radiculopathy (Sciatica) are here:
Fungal Meningitis Outbreak
Meningitis outbreak caused by compound pharmacy produced steroids for epidural injections, contaminated with Aspergillus fumigatus, infected more than 800 people across 20 states in 2012, 64 of whom died.
Percentage of People Who Experience Body Pain **
** Global Pain Index summary Report, 2016 , John Bell
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)
