Scilex Holding Company (D8B0)

Overview

Scilex Holding Company specializes in the acquisition, development, and commercialization of non-opioid pain management products aimed at treating both acute and chronic pain. The company's mission revolves around providing innovative solutions to manage pain without relying on opioids, addressing a critical need in the healthcare sector amidst the ongoing opioid crisis. Headquartered in Palo Alto, California, Scilex is at the forefront of developing and introducing novel therapeutics that offer relief for various pain conditions, thereby improving patient quality of life.

Products and Services

• ZTlido (lidocaine topical system) 1.8%

  A prescription lidocaine topical product designed for the relief of neuropathic pain associated with postherpetic neuralgia (PHN), a type of nerve pain that follows shingles. ZTlido is recognized for its ability to mitigate the discomfort associated with PHN, offering a non-opioid avenue for pain management.

• ELYXYB

  A ready-to-use oral solution intended for the acute treatment of migraine, with or without aura, in adults. ELYXYB provides a novel approach to managing migraines, presenting a targeted and convenient option for sufferers seeking rapid relief from migraine symptoms.

• GLOPERBA

  An oral liquid formulation of the anti-gout medication colchicine, indicated for the prophylaxis of painful gout flares in adults. GLOPERBA offers a preventive solution for managing gout, aiming to reduce the frequency and severity of gout attacks with its unique liquid delivery system.

Additionally, Scilex is actively engaged in the development of three promising product candidates:

• SP-102 (10 mg dexamethasone sodium phosphate viscous gel) (SEMDEXA)

  A novel viscous gel formulation of dexamethasone sodium phosphate for epidural injections, designed to treat lumbosacral radicular pain or sciatica. SEMDEXA has successfully completed a Phase 3 study, showcasing its potential as an effective treatment option for this common pain condition.

• SP-103 (lidocaine topical system) 5.4% (SP-103)

  A higher concentration formulation of ZTlido aimed at treating chronic neck pain and low back pain (LBP). Having completed a Phase 2 trial, SP-103 is on its path towards offering a potent non-opioid solution for chronic pain sufferers.

• SP-104 (4.5 mg low-dose naltrexone hydrochloride delayed-release capsules) (SP-104)

  A novel low-dose delayed-release formulation of naltrexone hydrochloride, currently under development for the treatment of fibromyalgia. With the successful completion of Phase 1 trials, SP-104 is a potentially groundbreaking treatment aiming at alleviating symptoms associated with fibromyalgia.