- SP-103 receives Fast Track Designation, which makes it eligible for some or all of the following:
- More frequent meetings or written communication with the FDA to discuss the SP-103 development plan and ensure collection of appropriate data needed to support drug approval.
- Eligibility for Accelerated Approval or Priority Review, if relevant criteria are met.
- Rolling Review, which means that Scilex can submit completed sections of its New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.
- More frequent meetings or written communication with the FDA to discuss the SP-103 development plan and ensure collection of appropriate data needed to support drug approval.
- Despite an overall lack of evidence to support their efficacy, opioids continue to be prescribed to treat acute LBP when patients seek medical evaluation.
- According to the CDC in 2020, LBP was the most common type of pain reported by patients, with 25% of U.S. adults reporting LBP in the prior 3 months.1
- LBP is estimated to have a total potential global market opportunity of approximately $10.0 billion by 2026.2
Scilex Holding Company, a Sorrento Company, Announces That the FDA Has Granted Fast Track Designation for SP-103 (Lidocaine Topical System) 5.4%, Next Generation Triple Strength Formulation of ZTlido®, for the Treatment of Acute Low Back Pain (LBP)
Aug 31, 2022
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