Scilex, a Sorrento Company, Announces Initiation of a Phase 2 Study to Evaluate the Safety and Efficacy of SP-103 in Subjects with Acute Low Back Pain

• Dosing of the first subject in a Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety and efficacy of SP-103 (lidocaine topical system) 5.4% in subjects with moderate to severe acute lower back pain (LBP). The trial will enroll 80 patients with acute lower back pain.
• SP-103 is a pharmacologically validated drug candidate and has the potential as a best-in-class agent of pain treatment for low back pain without the limitations of current therapies, including the addictive potential of opioids.
• An estimated 65 million adults in the U.S., or 25% of U.S. adults, suffer from acute low back pain¹ with a total potential global market opportunity of approximately $10.0 billion by 2026 (Brand Essence Research 2020).

Excerpt from the Press Release:

PALO ALTO, Calif., May 18, 2022 (GLOBE NEWSWIRE) — Scilex Holding Company (“Scilex”), a Sorrento Company (nearly 100% or over 99.9% majority-owned subsidiary of Sorrento Therapeutics, Inc.) (Nasdaq: SRNE, “Sorrento”) and a commercial biopharmaceutical company focused on developing and commercializing non-opioid therapies for patients with acute and chronic pain, announced dosing of the first subject in a Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety and efficacy of SP-103 in subjects with acute LBP.

“It is a significant milestone for Scilex to begin the next development phase of the triple-dose strength of FDA-approved ZTlido^® (lidocaine topical system) 1.8% (“ZTlido^®”). Most of the off-label use of topical lidocaine products is for the treatment of LBP. However, the low dosage strength of existing lidocaine products does not always provide sufficient pain relief³. A higher concentration of lidocaine per given area of a patch may lead to better efficacy and provide evidence for registering SP-103 for the treatment of acute LBP in patients with mostly superficial muscular pain. Based on the favorable data from the pharmacokinetics study, Scilex is advancing this program into Phase 2 with initiation of the study in LBP patients,” said Dr. Dmitri Lissin, Chief Medical Officer of Scilex.

“It is exciting to see a product in development with a higher concentration of lidocaine and great adhesion qualities. This product may greatly help patients with muscular pain in the lower back, and may also help to avoid use of systemic medications, associated with systemic side effects, including opioids,” said Alan Miller, M.D., Director of Interventional Pain Management at Coastal Spine & Pain Center, Fernandina Beach, Florida.

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