HomeInvesting NewsSorrento's Back Pain Treatment Receives "Fast Track" Status From the FDA

Sorrento’s Back Pain Treatment Receives “Fast Track” Status From the FDA

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Sorrento Therapeutics (NASDAQ:SRNE)

The FDA has granted Fast Track status to SP-103 (lidocaine topical system), an experimental medication and device product candidate developed by Sorrento Therapeutics (NASDAQ:SRNE) subsidiary Scilex Holding Company for the treatment of low back pain (LBP).

The foundation for SP-103 rests on the results of Ztlido 1.8%, Scilex’s flagship pain program that has received FDA approval. For treating LBP, researchers are testing SP-103, a topical system containing non-aqueous, triple-strength lidocaine. Scilex’s flagship pain medication Ztlido 1.8% and SP-103 are made using the same adhesive drug delivery formulation and manufacturing technology.

As of May, a double-blind, placebo-controlled phase II research of SP-103 (lidocaine topical system) 5.4% for acute LBP was approved by the Food and Drug Administration (FDA) by Scilex, which is owned by Sorrento. The business hopes to wrap up the current research by the end of the first quarter of 2023. Phase III of the candidate’s investigation will be designed based on the findings from phase II.

According to data compiled by the Centers for Disease Control and Prevention, back pain (LBP) is the most prevalent symptom reported by U.S. citizens. Approximately 25% of American adults experience sudden, severe LBP each year. As of 2026, SP-1-prospective 03’s market is estimated to be worth $10 billion worldwide.

Currently, there are no medications available that have been specially authorized for treating acute LBP. SP-103 can potentially be the first lidocaine topical medication approved by the FDA for the treatment of acute LBP. Given the size of the potential customer base, the green light should result in a substantial increase in sales for the business.

After the news was released, Sorrento Therapeutics (NASDAQ:SRNE) stock price increased by 5.67 percent on August 31. In contrast to the industry’s 24% fall year-to-date, Sorrento shares are down 55.9%.

Sorrento Therapeutics (NASDAQ:SRNE) pain portfolio includes Ztlido 1.8%, approved by the FDA to treat post-herpetic neuralgia pain, and SP-103 (PHN).

Resiniferatoxin (or “RTX”) is a naturally occurring, ultra-potent transient receptor potential vanilloid-1 agonist that the company is developing to treat persistent unpleasant pain. The company is gearing up for pivotal studies investigating RTX for cancer pain and moderate to severe osteoarthritis pain to develop RTX as a multi-indication franchise asset.

Scilex agreed to buy Ancora Medical, a privately held medical technology business, to bolster its pain portfolio.

Ancora’s Nerve Block Catheter Set, which has received FDA clearance for use in managing pain before, during, and after general and orthopedic surgery, will be added to the company’s assets due to the purchase.

Featured Image – Megapixl ©  Yur4you

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