Pivotal phase III SP-102 (Semdexa) data presentation at the American Society Of Interventional Pain (ASIPP) 2022 annual meeting.- Scilex Holding Company/Sorrento.
Scilex Holding Company , a Sorrento Company, announced pivotal Phase III Semdexa data presentation at the American Society of Interventional Pain 2022 annual meeting.
The pivotal Phase III SP-102 (Semdexa) trial has a highly positive results evaluating Semdexa in sciatica patients following an epidural injection was presented at the Innovation summit session of the 2022 American Society of Interventional Pain (ASIPP) Annual Scientific Meeting in Las Vegas, Nevada. Results from this multicenter, randomized, double-blind, placebo-controlled study demonstrated that patients experienced rapid onset of pain reduction in sciatica pain and the effect lasted for up to 99 days following a single injection of Semdexa at the end of the procedure. This is the first time this trial study data has been presented at a major North American medical meeting. The podium presentation described the Phase III trial, known as the C.L.E.A.R. trial program, randomized 401 lumbosacral radicular pain/sciatica patients at 40 sites across 25 states in the U.S., which is the largest double-blind randomized controlled epidural steroid injection clinical trial in sciatica.
The study met its primary endpoint with a highly statistically significant reduction in average daily leg pain in patients receiving Semdexa compared to placebo (p<0.001). a total of 401 sciatica patients were enrolled at 40 clinical sites in us. the median time (days) to repeat injection in placebo group was 57 and 99 days in the semdexa group, according to kaplan-meier estimation (p><0.001). safety analysis demonstrated a clean safety profile with no identified safety risks. there were no serious adverse events related to the drug or injection procedure, and no adverse events of special interest reported, such as hematoma and infection at the injection site, or paraplegia. the c.l.e.a.r trial also established the safety of repeat injections, as patients who experienced moderate-to-severe radicular pain between 4 and 23 weeks were allowed to receive open-label additional sp-102 (semdexa) injection.
The key secondary endpoint of Oswestry Disability Index, the gold standard for measuring degree of disability and estimating quality of life, showed a 28% improvement at 4 weeks on SP-102 (Semdexa) compared to baseline (minimal clinically meaningful improvement 8%-12%).
"These Phase III data demonstrate that the median time to repeat injection for patients treated with Semdexa was significantly longer than those treated with placebo," said Dmitri Lissin, SVP and CMO of Scilex Holding. "We believe these data coupled with Phase II results from our repeat-dose trial and earlier PK/PD trial in sciatica patients will help support product registration with the FDA and utility of Semdexa in a pain clinic setting. "
There is about 60% use of opioid pain medications for chronic back pain which is directly linked to many new persistent opioid users every year and up to many new cases of Opioid Use Disorder annually, making low back pain opioid use an important contributor to the opioid epidemic in the United States.
“With more than 30 million low back pain and sciatica patients every year in the US, there is enormous need for an approved treatment and a desperate need for effective non-opioid alternatives,” said Annu Navani, Secretary ASIPP and Medical Director, Comprehensive Spine & Sports Center and Adjunct Clinical Associate Professor, Stanford University School of Medicine. “Epidural steroid injections have been used more than half a century for low back and leg pain, and there has always been a need for safer, longer lasting and more efficacious formulations.”
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