- The U.S. Food and Drug Administration (FDA) granted fast track designation to Scilex's drug/device product candidate SP-103 to treat acute low back pain (LBP).
- Scilex — which is over 99.9% owned by Sorrento Therapeutics ( NASDAQ: SRNE ) — is developing SP-103 to be a non-opioid triple-strength, non-aqueous lidocaine topical system for acute LBP.
- "We are very pleased that the FDA has granted Fast Track designation for the non-opioid SP-103 program, the next generation triple strength formulation of ZTlido," said Scilex President and CEO Jaisim Shah.
- If approved, SP-103 could become the first FDA-approved lidocaine topical product to treat acute LBP, Scilex said in an Aug. 30 press release.
- Scilex is currently in the middle of a merger with SPAC Vickers Vantage I ( NASDAQ: VCKA ) and will go public on Nasdaq under the symbol SCLX.
- SRNE +13.40% to $2.20 premarket Aug. 31
For further details see:
Sorrento stock rises 13% on FDA fast track status for low back pain therapy SP-103