CHATHAM, NJ - Tonix Pharmaceuticals (NASDAQ:TNXP) has announced positive outcomes from a Phase 3 clinical trial of its non-opioid drug candidate, which could potentially introduce a new treatment for fibromyalgia without the risks of opioid addiction. The study revealed that the experimental drug not only reduced pain but also improved sleep and fatigue among patients with fibromyalgia, a condition that affects approximately 10 million Americans.
The drug, known as Tonmya™, is a sublingual tablet designed to target molecular mechanisms related to sleep quality, which is believed to be interconnected with fibromyalgia pain. In the latest trial, the medication demonstrated a statistically significant improvement in pain, with a p-value of 0.00005, indicating a strong likelihood that the results are not due to chance.
Tonix plans to seek FDA approval for Tonmya in the second half of this year, with the company's CEO expressing confidence in the drug's potential as a first-line treatment for newly diagnosed patients. The most common side effects reported were headache and somnolence in about 3% of patients, with no significant changes to weight or blood pressure, which are common issues with currently approved fibromyalgia drugs.
The current treatment landscape for fibromyalgia includes drugs like Lyrica®, Cymbalta®, and Savella®, which can cause side effects such as reduced energy or disrupted sleep. Many patients turn to opioids for relief, but this has led to concerns about addiction and a shift towards illegal drugs for some. Tonix's drug candidate aims to offer an alternative that avoids these pitfalls.
This information is based on a press release statement from Tonix Pharmaceuticals.
InvestingPro Insights
As Tonix Pharmaceuticals (NASDAQ:TNXP) makes strides with its promising non-opioid fibromyalgia drug, Tonmya™, potential investors and stakeholders are closely monitoring the company's financial health and stock performance. According to InvestingPro data, Tonix holds a market cap of approximately $22.63 million USD, reflecting its position in the biotech market. Despite the positive news on the clinical front, the company's operating income margin for the last twelve months as of Q3 2023 is reported at an alarming -3103.01%, indicating significant operating losses relative to its revenue, which stands at $3.99 million USD.
InvestingPro Tips suggest a mix of caution and opportunity for Tonix. On one hand, the company is not expected to be profitable this year, and it has been quickly burning through cash, which raises concerns about its financial sustainability. On the other hand, the stock has experienced a significant return over the last week, with a 17.01% price total return, and an even stronger return over the last month at 30.32%. These metrics highlight the stock's volatility and the potential for quick gains, albeit with a higher risk profile.
For those considering investment in Tonix Pharmaceuticals, it's important to weigh the promising potential of its drug candidate against the financial challenges the company faces. With more InvestingPro Tips available – a total of 13 for TNXP – investors can gain deeper insights and make more informed decisions. To explore these additional tips, visit InvestingPro's Tonix page. And remember, using the coupon code PRONEWS24 will get you an extra 10% off a yearly or biyearly Pro and Pro+ subscription, offering even more value as you navigate the volatile biotech sector.
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