Sorrento Therapeutics’ ( SRNE Quick Quote SRNE - Free Report) subsidiary Scilex Holding Company recently received Fast Track designation from the FDA for investigational drug and device product candidate SP-103 (lidocaine topical system) for the treatment of lower back pain (“LBP”).
SP-103 is built on data from Scilex’s FDA-approved flagship pain program, Ztlido 1.8%. SP-103 is a non-opioid triple-strength, non-aqueous lidocaine topical system being evaluated for LBP. SP-103 and Scilex’s flagship pain product Ztlido 1.8% share the same adhesive drug delivery formulation and manufacturing technology.
In May, Sorrento-owned Scilex received an FDA clearance to initiate a double-blind, placebo-controlled phase II study of SP-103 (lidocaine topical system) 5.4% for acute LBP. The company intends to complete the ongoing study by the first quarter of 2023. Based on the phase II results, the phase III study of the candidate will be planned.
According to a
report by the Centre of Disease Control and Prevention(CDC), the most common type of pain reported by patients in the United States is LBP. It is estimated that nearly 25% of adults in the United States suffer from acute LBP. The target market for SP-1-03 has a global market potential of reaching $10 billion by 2026.
Presently, there are no approved medicines specifically indicated for acute LBP. If approved, SP-103 can become the first FDA-approved lidocaine topical product for acute LBP. Since the target market represents a significant opportunity, the approval should bring in significant revenues for the company.
Post the announcement of the news, the stock price of Sorrento surged by 5.67% during market hours on Aug 31. However, Sorrento shares have declined 55.9% in the year-to-date period compared with the
industry’s decline of 24%. Image Source: Zacks Investment Research
Apart from SP-103, the company’s pain portfolio consists of its FDA-approved Ztlido 1.8% for relieving pain associated with post-herpetic neuralgia (PHN).
It is also developing Resiniferatoxin (“RTX”), a naturally occurring and ultra-potent transient receptor potential vanilloid-1 agonist to reduce long-lasting noxious chronic pain symptoms. The company intends to develop RTX as a multi-indication franchise asset and is preparing the candidate for its pivotal studies evaluating it for pain associated with cancer ad moderate to severe osteoarthritis pain.
To further strengthen its pain portfolio, Scilex entered into an agreement to acquire Ancora Medical, a privately held medical technology company.
The acquisition will add Ancora’s FDA-approved key asset, its Nerve Block Catheter Set, indicated for surgical pain management during pre-operative, perioperative and postoperative periods associated with general and orthopedic surgery.
Zacks Rank and Stocks to Consider
Currently, SRNE has a Zacks Rank #3 (Hold).
Some better stocks in the same sector are
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