PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX), a company specializing in non-opioid pain management, has announced the publication of positive Phase 3 trial results for its product SP-102 (SEMDEXA™), potentially the first FDA-approved corticosteroid for epidural injections. The study findings, featured in PAIN, the official journal of the International Association for the Study of Pain, indicate that SP-102 provides significant pain reduction and improvement in disability for sciatica patients.
The C.L.E.A.R. Trial, which stands as the largest known randomized controlled trial in sciatica using epidural steroid injections, enrolled 401 subjects suffering from low back pain due to unilateral intervertebral lumbar disc herniation. The trial met its primary and secondary endpoints, showing a clinically meaningful decrease in pain intensity and disability index scores over a month, with a safety profile comparable to placebo.
According to Dr. Alan Miller, Principal Investigator from Coastal Clinical Research Specialists, SP-102 could offer a safer alternative to current off-label steroid formulations used for epidural administration. No serious adverse events related to the drug or injection procedure were reported, and the trial also confirmed the safety of repeat injections.
This announcement is particularly significant as there are currently no FDA-approved therapies for the treatment of lumbosacral radicular pain, commonly known as sciatica. SP-102, which received Fast Track status from the FDA in 2017, could provide a new, approved treatment option for the millions of adults suffering from this debilitating condition.
Scilex, headquartered in Palo Alto, California, focuses on the acquisition, development, and commercialization of non-opioid pain management products. The company's portfolio includes FDA-approved treatments for postherpetic neuralgia, acute treatment of migraine, and prophylaxis of gout flares.
The information in this article is based on a press release statement from Scilex Holding Company.
In other recent news, Scilex Holding Company has been making significant strides in the medical field. The company recently launched GLOPERBA®, the first oral liquid medication for gout flare prevention in the United States. This development caters to the growing patient population, estimated to be over 70% of gout patients who have comorbid conditions.
Scilex also secured FDA approval for the commercial manufacturing of Gloperba®, a treatment for the prevention of painful gout flares. This approval will enable the product to be available in major U.S. wholesalers and pharmacies.
In recent developments, Scilex reached a settlement in a patent lawsuit with Takeda Pharmaceuticals over Gloperba. The settlement agreement, endorsed by the U.S. District Court for the District of Delaware, has allowed Scilex to submit the Consent Judgment to the FDA, seeking final approval for the proposed label expansion of Gloperba.
Analysts from H.C. Wainwright have adjusted their outlook on Scilex shares, reducing the price target to $8.00 from the prior $12.00, while maintaining a Buy rating on the stock.
Finally, Scilex has secured a definitive agreement with certain institutional investors for a registered direct offering involving the sale of 15 million shares of common stock and warrants, with anticipated gross proceeds of approximately $15 million.
InvestingPro Insights
In the wake of Scilex Holding Company's (NASDAQ:SCLX) announcement regarding SP-102, a closer look at the company's financial health and stock performance as provided by InvestingPro offers a comprehensive picture. Despite the promising trial results, Scilex operates with a significant debt burden and may have trouble making interest payments on its debt, as indicated by InvestingPro Tips. This could be a concern for investors considering the long-term viability of the company.
InvestingPro Data shows a market capitalization of $179.26 million USD, reflecting the company's size in the market. Additionally, the data indicates a negative Price/Earnings (P/E) ratio of -1.11 and an adjusted P/E ratio for the last twelve months as of Q1 2024 of -1.15, suggesting that investors are anticipating future growth despite the company not being profitable over the past year. The revenue growth over the same period stands at 12.54%, which may be seen as a positive sign of the company's potential to increase its financial performance.
Moreover, the stock has experienced a significant return over the last week with a 36.7% price total return, reflecting a strong short-term investor sentiment. This contrasts with the 80% drop in the one-year price total return, emphasizing the stock's volatility and the potential risks associated with investing in Scilex.
For investors seeking more insight into Scilex's performance and future prospects, there are additional InvestingPro Tips available. These tips delve deeper into the company's financial metrics and stock behavior, providing valuable guidance for those considering an investment in Scilex. Use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking access to a wealth of expert analysis and tips.
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