Tonix Pharmaceuticals, Set to File an NDA for Tonmya for the Management of Fibromyalgia, is Planning Expected Launch in 2H 2025
Tonix Pharmaceuticals (NASDAQ:TNXP) is preparing to file a New Drug Application (NDA) for Tonmya, its fibromyalgia management drug, in the second half of 2024. The company anticipates FDA approval and commercial launch in the second half of 2025. Tonmya, a non-opioid sublingual tablet, has shown significant improvements in fibromyalgia pain, sleep quality, and other symptoms in clinical trials.
The fibromyalgia market, valued at over $3 billion globally in 2023, has not seen a new FDA-approved drug in over 15 years. Tonix aims to compete in this growing market, which is expected to expand at a 3.8% CAGR from 2024 to 2030. With Tonmya's unique mechanism of action and promising clinical results, Tonix is positioned to potentially disrupt the market currently dominated by generic versions of previous blockbuster drugs.
- Tonmya showed statistically significant improvement in fibromyalgia pain (p-value of 0.00005) in Phase 3 trial
- Tonmya demonstrated improvements in sleep quality, depression, fatigue, and overall fibromyalgia symptoms
- Tonix is entering a $3 billion global market with potential for growth
- Tonmya offers a new therapeutic class for fibromyalgia, differentiating it from current treatments
- Tonmya is still an investigational drug and not yet approved by the FDA
- Potential competition from another new drug candidate also heading for FDA approval
- Tonix faces competition from established generic versions of previous blockbuster fibromyalgia drugs
Insights
The announcement of Tonix Pharmaceuticals' plan to file a New Drug Application (NDA) for Tonmya is of significant importance to investors. The move follows promising Phase 3 trials, which demonstrated a statistically significant improvement in fibromyalgia pain, sleep quality and other associated symptoms. The p-value of 0.00005 indicates an exceedingly low probability that these results were due to chance.
The potential market for Tonmya is considerable. With fibromyalgia affecting approximately 2.7 million diagnosed and treated patients in the US alone and the global market valued at over
The financial outlook looks particularly promising, especially given the lack of new FDA-approved fibromyalgia treatments in the past 15 years. If approved, Tonmya could capture a significant market share due to its novel approach, targeting sleep quality rather than sleep quantity. Investors should be mindful of the risks, such as the competitive landscape and the reliance on FDA approval, but the potential rewards are noteworthy.
Tonix Pharmaceuticals' Tonmya addresses a significant unmet need in the fibromyalgia treatment landscape. The drug's focus on improving sleep quality rather than quantity is innovative and could offer a substantial therapeutic benefit. Traditional sleep aids tend to manage the amount of sleep but often fail to improve the quality, which is important for fibromyalgia patients.
The drug being a non-opioid and non-addictive sublingual tablet makes it particularly appealing. The favorable safety profile, with the most common adverse events being minor and transient, adds to its attractiveness. The high prevalence of fibromyalgia and the lack of new approved treatments over the past decade make this an exciting development in the field.
The competitive landscape will be interesting to monitor, especially with another drug targeting norepinephrine making its way through the FDA. However, Tonmya’s unique mechanism of action and strong clinical trial results position it well to make a substantial impact.
The announcement signals a potential shift in the fibromyalgia treatment market. The historical context, with the market largely stagnant and dominated by older drugs now generic, sets the stage for Tonmya's entry. The potential rivalry with another new drug could reignite interest and competition in the fibromyalgia space, benefiting patients through improved treatment options.
Tonmya's innovative approach and the drug's focus on a differentiated aspect of fibromyalgia management—sleep quality—provide a clear competitive edge. The promising clinical results and strategic timing of the NDA filing suggest that Tonix Pharmaceuticals could capture significant market share if approved.
Understanding Tonmya's potential to disrupt the market, investors should watch for FDA updates and market reactions. The commercial launch, if successful, could drive substantial revenue growth for Tonix Pharmaceuticals, reflecting positively on the stock.
CHATHAM, NJ / ACCESSWIRE / July 17, 2024 / With the completion of its final pre-NDA meeting with the FDA, Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) announced it is filing an NDA submission in 2H 2024 and laying plans for the commercial launch of Tonmya™* for the management of fibromyalgia, assuming approval by the FDA in 2H 2025.
The fibromyalgia market has not seen a new FDA-approved drug in over 15 years. And now with two drugs making their way through the FDA - Tonix's Tonmya and one from another U.S. company - there could be the prospect of a two-drug rivalry reminiscent of the 2010s when two blockbuster fibromyalgia drugs together created
Fibromyalgia Landscape
According to an opportunity analysis commissioned by Tonix and carried out by Eversana for Tonix's drug, Tonmya™, fibromyalgia affects around 2.7 million diagnosed and treated patients in the United States. Despite the high prevalence of this condition, the treatment landscape has remained largely stagnant for over 15 years. The last approved medication was approved in 2009, and two earlier ones were approved in 2008 and 2007.
Despite widely reported side effects and tolerability issues, the two biggest selling fibromyalgia drugs generated combined peak sales of approximately
Tonix will be competing for a slice of a global market that was valued at over
Tonix Enters the Ring with Tonmya
Tonmya is a new therapeutic class and unlike the three currently approved fibromyalgia drugs, which are involved in the uptake of both serotonin and norepinephrine or are more specific for norepinephrine than serotonin. The other new drug candidate heading for FDA approval is very specific for norepinephrine and does not affect serotonin.
Tonmya (also known as TNX-102 SL) is a non-opioid, non-addictive sublingual tablet designed for bedtime use. Tonmya is a sublingual formulation of cyclobenzaprine hydrochloride, which has improved sleep quality in clinical studies. Sleep quality is different than sleep quantity - or the amount of time spent asleep. By focusing on sleep quality, Tonmya is different from conventional sleep drugs. Traditional sleep aids like Ambien® fail to manage the type of sleep disturbances that exacerbate fibromyalgia symptoms.
In the latest Phase 3 trial, Tonmya showed a statistically significant improvement in fibromyalgia pain with a p-value of 0.00005. Tonix reports that statistically significant results were also seen in improving sleep quality, reducing depression and fatigue and improving overall fibromyalgia symptoms and function. Tonmya was well tolerated and the most common adverse events were transient sensations in the mouth corresponding with the disintegration of the tablets under the tongue.
Tonmya has been conditionally accepted by FDA as a trade name for the management of fibromyalgia. Tonix says it will file a new drug application (NDA) with the FDA in the second half of this year and has completed both manufacturing and multi-disciplinary-focused pre-NDA meetings with FDA.
As the anticipated NDA filing and FDA approval dates for Tonmya and a second new drug draw near, a battle in the fibromyalgia market heats up. Tonix Pharmaceuticals, with its innovative approach and promising clinical trial results, could be well positioned to disrupt a market long dominated by a few large players.
Click here for more information on Tonix Pharmaceuticals: https://redingtonvirtual.com/tnxp-aw-2407/
*Tonmya is an investigational new drug and is not approved for any indication
Investor Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182
Important notice, please read: Certain statements in this document are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, , risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the "SEC") on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Tonix Pharmaceuticals Holding Corp. for investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein.
SOURCE: Tonix Pharmaceuticals Holding Corp.
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