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Sorrento's Scilex Holding Company Says Expects to Complete Enrollment In SP-102 (SEMDEXA) Phase 3 Pivotal Trial Program In 2020

Preliminary Q3 2020 net sales of ZTlido® of approximately $7.2 million, quarter-over-quarter growth of 26% compared to $5.7MM in Q2-2020 despite the continued impact of

· 10/07/2020 06:02
  • Preliminary Q3 2020 net sales of ZTlido® of approximately $7.2 million, quarter-over-quarter growth of 26% compared to $5.7MM in Q2-2020 despite the continued impact of COVID-19 pandemic.
  • The Phase 3 pivotal trial investigating SP-102 non-opioid therapy for lumbosacral radicular pain/ sciatica is over 90% enrolled and top-line data is expected to be announced by Q2-2021, despite the ongoing COVID-19 pandemic, which delayed or put on hold hundreds of other clinical trials around the world.
  • SP-102 could potentially be the first FDA approved epidural steroid product for the treatment of sciatica with the potential to replace the current 10 to 11 million off-label epidural steroid injections administered each year in the U.S.

PALO ALTO, Calif., Oct. 07, 2020 (GLOBE NEWSWIRE) -- Scilex Holding Company ("Scilex"), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (NASDAQ:SRNE, ", , Sorrento", , ))))), today announced continuous sales growth in ZTlido® from quarter to quarter in 2020. Scilex expects third quarter 2020 ZTlido® net sales to grow 26% to approximately $7.2MM, compared to $5.7MM in Q2-2020. The preliminary third quarter 2020 net sales information presented in this press release is based on Scilex's current expectations and may be adjusted as a result of, among other things, completion of customary quarterly review procedures.

Scilex's SP-102 (SEMDEXA™) is currently being evaluated in a pivotal Phase 3 clinical trial in the U.S. to evaluate patients with lumbosacral radicular pain/sciatica. The trial is expected to complete enrollment in the fourth quarter of 2020 and top-line data is expected in the second quarter of 2021.   Scilex intends to use the results from this pivotal Phase 3 trial to discuss with U.S. health authorities the basis for licensure application to the U.S. Food and Drug Administration (FDA) for this high unmet need indication where no treatments have been approved and which is responsible for millions of people suffering in the U.S. alone. Scilex has extensive clinical and pre-clinical data (including multiple Phase 2 clinical trials) with the novel viscous formulation of SP-102, which was designed to provide extended local effect for sciatica patients. The robust data collected over the course of the company's multi-year clinical development program will be presented to the U.S. FDA as part of a new drug application.  

The CLEAR ("Corticosteroid Lumbar Epidural Analgesia for Radiculopathy") clinical study is a randomized, double-blind, placebo-controlled Phase 3 trial that is expected to enroll 400 patients with lumbosacral radicular pain at 40+ sites across the U.S. The primary endpoint of the study is mean change in the Numeric Pain Rating Scale (NPRS) for leg pain with SP-102 epidural injection compared to intramuscular injection of placebo over four weeks. The secondary endpoints include other measures of pain at 4 and 12 weeks as well as time to repeat injection of SP-102, safety and function. The study includes an open-label extension to build the safety database of patients treated with SP-102.   "We are anxiously awaiting a new injectable formulation of dexamethasone and registration for treatment of radicular pain based on results of a large, randomized placebo-controlled multi-center trial. If approved by the FDA, SP-102 would be the first corticosteroid for epidural injections addressing safety issues with steroid medications, currently used off-label, and an important addition to armamentarium of interventional pain physicians," said Dr. Steve Cohen, Chief of Pain Medicine and Professor of Anesthesiology & Critical Care Medicine, Neurology and Physical Medicine & Rehabilitation, Johns Hopkins School of Medicine, and Professor of Anesthesiology and Physical Medicine & Rehabilitation, Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences.

SP-102 is a novel, non-opioid injectable viscous gel formulation in development for the treatment of lumbosacral radicular pain, containing no neurotoxic preservatives, surfactants, solvents or particulates. The SP-102 formulation is administered by epidural injection. Based on preclinical and clinical studies conducted to date, it extends the residency time at the site of injection and has not demonstrated the safety concerns that led the FDA to issue a class warning on the currently off-label use of injectable corticosteroids to include information about the risk of serious neurologic events with epidural steroid injections (ESIs).

"Lumbosacral radicular pain, otherwise known as sciatica, is commonly treated by off-label epidural steroid injections. There are an estimated ten to eleven million epidural steroid injections administered per year in the U.S. alone and there are no approved steroids for epidural injections.2 The clinical results for the pivotal Phase 3 trial for SP-102 will be a seminal milestone for Scilex and may provide encouraging news for the many millions of people who are confronting debilitating radicular pain/sciatica. We believe that SP-102 could be the first FDA-approved epidural steroid product for patients suffering from this common, painful condition," said Jaisim Shah, President and Chief Executive Officer of Scilex.

In 2019, the overall estimated number of ESI procedures in the U.S. was 11.6 million across all Medicare and private coverage patients, with lumbar radiculopathy / sciatica procedures comprising approximately 88% of all ESIs administered. Despite widespread utilization of ESIs, concerns persist in the market about particulate steroids and potential side effect and safety concerns (e.g., stroke) from current off-label use. As a result, a significant unmet medical need exists within the market for a potent, non-particulate ESI formulation that demonstrated safety and effectiveness in controlled clinical trial evaluations.1  

In the U.S., more than 30 million people live with low back and radicular pain, with this population expected to grow as the population ages.4,5 Many patients experience moderate to severe pain with intolerance and/or inadequate response to current analgesic therapies such as opioids and nonsteroidal anti-inflammatory drugs (NSAIDs).6,7 There is a great need for highly effective analgesic medications to provide patient relief without the toxicity and tolerability challenges of NSAIDs and opioids.5 Opioid prescriptions account for about 40 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.5,8

Chronic pain affects 100 million, or almost one- in-three, Americans9, with nearly 33 million patients suffering from lower back pain in the U.S.10, and costs the United States approximately $560 to $635 billion annually., Government agencies, physicians, patients, and payers are looking for alternatives to opioids to reduce the risk of dependency or addiction, and serious side effects (such as respiratory depression and constipation), while still offering potent solutions for people living with chronic pain.