Scilex, a Sorrento Company, Highlights Safety Data From Phase 1 Trial of SP-104, a Proprietary Low Dose Naltrexone for Fibromyalgia

• SP-104 is a novel, proprietary, fixed dose, delayed burst release of low dose naltrexone hydrochloride, 4.5 mg, for treatment of fibromyalgia (FM).
• There is a clear medical need for new, safe and effective treatments with the potential to improve care for the estimated 10 million FM patients in the U.S. and more than 200 million worldwide
• Phase 1 clinical trial data showed that SP-104 treated healthy volunteers and had lower rates of adverse events, as compared with immediate release naltrexone -treated volunteers.

Excerpt from the Press Release:

PALO ALTO, Calif. and SAN DIEGO, May 11, 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 today that safety data from Scilex’s Phase 1 clinical trial demonstrated that SP-104 was better tolerated than immediate release naltrexone hydrochloride 4.5 mg at the same dose in healthy volunteers. A second Phase 1 pharmacokinetic trial has completed enrollment and results will be available soon.

SP-104 is a novel, proprietary, fixed dose, delayed burst release of low dose naltrexone, for the treatment of FM and has an end goal of reducing side effects associated with formulations of immediate release naltrexone and FM disease burden. SP-104 has key clinical data supporting its use in the treatment of FM. Prior investigational trials support the use and development of SP-104, delayed burst release naltrexone hydrochloride 4.5 mg, for FM. Currently there are no low-dose formulations (i.e., less than 5 mg) available. Physicians currently use the commercially available high-dose tablets (naltrexone hydrochloride 50 mg) and have compounding pharmacies aliquot lower doses for patients. Pharmacy-compounding is inherently inaccurate and does not involve analyses to confirm that the aliquoted product has the target level of drug, and there is no assurance as to content uniformity within a batch as well as other quality attributes critical for pharmaceutical product performance. This can lead to errors in dosing and challenges with titration. The commercial products and pharmacy-compounded products also allow for the immediate release of the drug in the stomach, which can lead to compliance challenges due to severe side effects. Common side effects for naltrexone include hyperalgesia, dysphoria, insomnia and anxiety. All these issues culminate into patient compliance issues and result in the eventual abandonment of an otherwise viable therapy to treat this debilitating disease. SP-104 uses delayed burst release technology that bypasses the stomach and releases the drug in the gut (upper intestine). When taking SP-104 at night before bed, peak drug levels are achieved at night during sleep, allowing the patient to avoid conscious perception of hyperalgesia and other side effects. The combination of the delayed-release and administration at night may also maximize efficacy as most endorphin/enkephalin release is during sleep, which maximizes the product’s potential to elicit compensatory response.

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