A Redux Of The Lyrica-Cymbalta Fibromyalgia War Of The 2010s May Look More Like David Vs. Goliath

The following post was written and/or published as a collaboration between Benzinga's in-house sponsored content team and Tonix Pharmaceuticals Holding Corp. The sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.

The fibromyalgia treatment market appears set for a potential shake-up as micro-cap firm Tonix Pharmaceuticals Holding Corp. TNXP and midcap Axsome Therapeutics AXSM both guide to filing for FDA approval with their drugs this year. Both companies have promising fibromyalgia treatments looking to get FDA approval in 2025 – potentially reshaping a market that has not seen a new FDA-approved drug in over 15 years.  The prospect of two new fibromyalgia drugs is reminiscent of the Lyrica® – Cymbalta® rivalry in the 2010s.

While the Pfizer PFE – Eli Lilly LLY rivalry was a battle between two giants, the upcoming fibromyalgia rivalry looks more like David and Goliath. Tonix has a market cap of just about $12 million compared to Axsome's close to $4 billion. Already, Tonix markets two prescription drugs for migraine headaches, and Axsome markets an antidepressant and a treatment for narcolepsy.

The 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 Savella®, in 2009 which was developed by Forest Labs and Cypress Biosystems and is now owned by AbbVie. Lyrica, made by Pfizer, was approved in 2007, and Cymbalta, developed by Eli Lilly, was approved in 2008.  

Despite widely reported side effects and tolerability issues, Cymbalta and Lyrica generated combined peak sales of approximately $10 billion. Savella achieved peak sales of only about $200 million. Both Cymbalta and Lyrica have gone generic, while Savella is still proprietary.  A big difference about the fibromyalgia market today is that the condition is widely accepted.  Before Pfizer and Eli Lilly marketed Lyrica and Cymbalta, many doctors doubted the existence of fibromyalgia due to the lack of visible physical signs and specific diagnostic tests. Many believe that fibromyalgia was overlooked because it affects mostly women.

Tonix and Axsome will be competing for a slice of a global market that was valued at over $3 billion in 2023 and is expected to grow at a compound annual growth rate of 3.8% from 2024 to 2030. Tonix has not guided to peak sales, but Axsome guidance – which can be found on its website – estimates that its AXS-14 product will reach peak sales of between $500 million and $1 billion.

Tonix Enters The Ring With Tonmya

Axsome's drug, AXS-14, is based on a norepinephrine reuptake inhibitor similar to Savella and Cymbalta. Tonix's Tonmya is a new therapeutic class and unlike Lyrica, Cymbalta or Savella.  Cymbalta and Savella are both SNRI's and inhibit the uptake of both serotonin and norepinephrine. Savella is more specific for norepinephrine than serotonin. AXS-14, or esreboxetine, 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. It is a sublingual formulation of cyclobenzaprine hydrochloride, which has improved sleep quality in clinical studies. Sleep quality is different from sleep quantity, or the amount of time spent asleep. Tonix plans to differentiate Tonmya from conventional sleep drugs through its focus on sleep quality. 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 to the disintegration of the tablets under the tongue.

Tonmya has been conditionally accepted by the 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 the FDA.

As the anticipated NDA filing and FDA approval dates for Tonmya and Axsome’s fibromyalgia drugs draw near, the David vs. Goliath 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.

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*Tonmya is an investigational new drug and is not approved for any indication.

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