- The lifetime prevalence of neck pain in the adult population is estimated to range from 14.2% to 71% with a mean of 48.5%.2 There are currently no approved medical treatments for neck pain in the U.S.
- The study was a randomized, double-blind, placebo-controlled crossover trial performed at four U.S. military, Veterans Administration, academic, and private practice sites, in which 76 patients were randomized to receive either a placebo patch followed by ZTlido® for 4-week intervals or vice versa.
- Overall, separation between ZTlido® and placebo effects and variability observed in this patient population provided necessary estimates for planning a potential Phase 3 development trial of SP-103 (triple-strength formulation of ZTlido®) which contains 3-times higher concentration of lidocaine and has completed a Phase 2 trial in acute back pain.
PALO ALTO, Calif., Feb. 20, 2024 (GLOBE NEWSWIRE) — Scilex Holding Company (NASDAQ:SCLX, “Scilex” or “Company”))))), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced publication in Anesthesiology Journal of results from an investigator-initiated research study using ZTlido® for the treatment of chronic neck pain.
The lifetime prevalence of neck pain in the adult population is estimated to range from 14.2% to 71% with a mean of 48.5%.2 The global market for topical medications is projected to increase from $4.8 billion per year in 2021 to $7.3 billion per year in 2031.3 There are currently no approved medical treatments for neck pain in the U.S. The study was a randomized, double-blind, placebo-controlled crossover trial performed at four U.S. military, Veterans Administration, academic, and private practice sites, in which 76 patients were randomized to receive either a placebo patch followed by ZTlido® for 4-week intervals or vice versa. The primary outcome measure was mean reduction in average neck pain coupled with the Patient Global Impression of Change.
The study demonstrated a clinical benefit trend for ZTlido® in treatment of neck pain, where 27.7% of patients experienced a positive outcome on ZTlido®, versus 14.9% on placebo. The effect was more pronounced during the first study period, reaching statistical significance. Analysis of both treatment periods did not show significant results due to the carry-over effect of the crossover study design and less than anticipated sample size due to early termination of the study (COVID pause and drug expiration). A positive trend was also observed for corresponding neck disability index.
Overall, separation between ZTlido® and placebo effects and variability observed in this patient population provided necessary estimates for planning a potential Phase 3 development trial of SP-103 (triple-strength formulation of ZTlido®), which contains 3-times higher concentration of lidocaine. Additionally, this study provided essential insight into selection of patient population responsive to topical lidocaine treatment. Application of ZTlido® was well-tolerated and safety profile consistent with other ZTlido® trials previously conducted by Scilex.
“Given the strong signal for clinically meaningful efficacy, our study results point to a potential necessity of further investigation of topical lidocaine treatment, especially in a formulation that contain higher dose and greater skin penetration than currently available alternatives, as it may provide greater clinical benefit to patients with chronic neck pain,” said Principal Investigator, Dr. Steven P. Cohen, Chief of Pain Medicine and Professor of Anesthesiology & Critical Care Medicine, Neurology, Physical Medicine & Rehabilitation, and Psychiatry & Behavioral Sciences at the Johns Hopkins School of Medicine, and Professor of Anesthesiology and Physical Medicine & Rehabilitation at Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences.
“This proof-of-principle study data using ZTlido® in addition to our recently published skin penetration data demonstrating passive diffusion of lidocaine from SP-103 into a muscle layer, provide support for our strategy to pursue chronic neck pain indication for our next generation topical lidocaine system, aiming to become the first therapy approved for such common medical condition with significant unmet need for safe and effective non-addictive treatment,” said Dmitri Lissin, M.D., Chief Medical Officer of Scilex.
Neck pain, or cervicalgia, is one of the most common pain presentations in U.S. and the 4th leading cause of disability. In the U.S., 52.9M adults suffer from Neck Pain.4 Prevalence of Neck Pain is estimated at greater than 20% of the adult population in the U.S. 4 In 2022, it was reported that neck pain was responsible for job absences among 25.5 million Americans, who missed an average of 11.4 days of work per year4. According to a 2020 JAMA publication (Journal of the American Medical Association), the U.S. low back and neck pain market is estimated at $134.5B.4
