The Rush for Non-Addictive Painkillers to Counter the Opioid Crisis Puts Two Companies Close to FDA Decisions

This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.

CHATHAM, NJ / ACCESSWIRE / October 1, 2024 / As the opioid crisis continues to devastate communities and strain healthcare systems, the demand for safer, non-addictive pain management options remains urgent. Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) is looking to be at the forefront of this shift, developing an innovative solution that could reshape chronic pain treatment. Central to Tonix's strategy is TNX-102 SL*, a non-opioid investigational drug targeting fibromyalgia, a chronic pain condition that affects millions of Americans.

Tonix is one of several biopharmaceutical companies responding to the call for non-addictive painkillers. The FDA's Fast Track designation of TNX-102 SL for fibromyalgia highlights the critical need for new treatments in chronic pain management. The FDA has granted Priority Review status to VX-458 from Vertex Pharmaceuticals. VX-458 is a non-opioid drug for acute pain.

The Market is Ready for Non-Opioid Pain Solutions

The broader pain management market has faced numerous setbacks in recent years. Past attempts to introduce new treatments have often been met with regulatory challenges or unforeseen side effects. For instance, anti-NGF monoclonal antibodies, pursued by pharmaceutical giants like Pfizer and Eli Lilly, Johnson and Johnson and AstraZeneca did not achieve their desired results due to increased risks of joint damage. Before that, painkillers like Vioxx from Merck and Celebrex from Pfizer were challenged for heart attack and stroke risks, even prompting Merck to enact a global product withdrawal for Vioxx.

Chronic pain is a complex and often debilitating condition, affecting an estimated 100 million Americans, with fibromyalgia and long COVID contributing millions each to that count. Fibromyalgia, a common chronic pain condition, impacts approximately 10 million people in the U.S. alone. Fibromyalgia was long overlooked because it affects mostly women and the medical establishment and pharmaceutical industry did not historically focus on health issues affecting mostly women. Even today, the three FDA-approved treatments for fibromyalgia are limited by side-effects, and many patients resort to opioids, despite their risks. In fact, research indicates that 21% to 29% of patients prescribed opioids for chronic pain misuse them, with up to 12% developing opioid use disorder.

Tonix Pharmaceuticals aims to change this with TNX-102 SL, a first-in-class non-opioid drug designed to target the disturbed sleep in fibromyalgia, which the company believes is closely linked to origins of pain in fibromyalgia patients. By addressing sleep disturbance, TNX-102 SL offers a new mechanism of action from existing treatments for managing fibromyalgia pain without the dangers of opioids.

Tonix is nearing the submission of its new drug application (NDA) for TNX-102 SL, which is expected in October 2024 - just weeks from now. The company plans to request Priority Review, which could expedite the regulatory process and bring the treatment to market sooner. If approved, Tonix reports that TNX-102 SL would be the first new pharmacotherapy for fibromyalgia in more than 15 years, offering a groundbreaking option for patients who have long struggled with inadequate treatment options.

The Push for Non-Addictive Painkillers

Tonix's TNX-102 SL is part of a broader movement within the pharmaceutical industry to develop non-addictive pain treatments. This shift is being driven, in part, by the federal government's focus on curbing opioid addiction, which has become a public health emergency. In 2020 alone, the opioid epidemic cost the U.S. economy an estimated $1.5 trillion, largely due to the social, healthcare and criminal justice consequences of addiction.

Recognizing the dangers of opioid use, the U.S. government has been actively encouraging the development of alternatives such as through initiatives like the HEAL (Helping to End Addiction Long-term) Initiative, an aggressive, trans-agency effort that is funding more than 1,000 projects nationwide to speed scientific solutions to stem the national opioid public health crisis.

While Tonix's TNX-102 SL focuses on chronic pain management, Vertex's VX-458 addresses acute pain, a market that includes over 80 million U.S. patients annually, according to Vertex's estimates. VX-458 is a non-opioid treatment that interrupts pain signaling without engaging opioid receptors, significantly reducing the risk of addiction. Vertex has already filed the NDA for VX-458 based on pain relief in surgical studies of bunionectomy and abdominoplasty or "tummy tuck". The FDA has granted VX-458 Priority Review status, signaling its importance in addressing the acute pain market. Both Tonix and Vertex's efforts represent potentially crucial steps in reducing opioid reliance for chronic and acute pain, respectively.

Navigating the Complex World of Pain

Understanding pain and how to treat it effectively requires recognizing its complexity. Pain is not a one-size-fits-all experience - it varies in duration and type. Pain can be acute or chronic. Also, three distinct types of pain are recognized, and each type responds to different medicines. Fibromyalgia represents one of the most challenging forms of pain because it is the prototypic example of nociplastic pain, which has only been recognized by scientists in the past few years. Noicplastic pain is always chronic. Nociplastic pain originates in the brain and only responds to drugs that act in the brain. Tonix's TNX-102 SL acts on nociplastic pain in the brain.

In contrast, there are two types of pain that originate in the periphery, or outside the brain. The "periphery" means arms, legs and even organs. Nociceptive pain is the type that signals real or impending tissue damage. Nociceptive pain can be acute or chronic. Nociceptive pain represents the normal functioning of the pain system. Nociceptive pain is the target for Vertex's VX-458, which targets a protein in the body called NaV1.8, expressed in peripheral tissues, which is mutated in people who cannot experience pain and subsequently lose fingers and toes.

The final type of pain is called neuropathic pain, and stems from nerve damage, like sciatica or shingles. Neuropathic pain is relatively well-understood and is typically treated by relieving the problem that's damaging the nerve. For sciatica this may involve surgery to relieve the nerve compression. For shingles, this may involve treating the zoster infection with medicines for herpes.

Fibromyalgia represents one of the most challenging forms of nociplastic pain because it is widespread and often unrelenting. Also, fibromyalgia is typically associated with sleep disturbance and fatigue. Traditional treatments, including opioids, have been insufficient in addressing this type of pain. Opioid misuse has worsened the problem, as many patients turn to these drugs for relief despite the lack of evidence supporting their efficacy in treating fibromyalgia.

Tonix's TNX-102 SL offers a promising alternative by focusing on targeting disturbed sleep, which plays a crucial role in how the brain processes pain signals. Research shows that improved sleep quality is strongly associated with reduced pain in fibromyalgia patients. This approach distinguishes TNX-102 SL from currently common therapies and potentially represents a much-needed advance in the management of fibromyalgia's chronic pain. Tonix intends to apply for Priority Review next month (in October) at the time of filing the NDA for TNX-102 SL for fibromyalgia.

These treatments reflect how new science and the commitment of industry and academia can be mobilized to bring non-opioid treatments to market. Both Tonix's TNX-102 SL and Vertex's VX-458 have received FDA Fast Track designations. These designations are granted to important new drugs that address serious medical conditions and have the potential to fill unmet medical needs.

The Future of Pain Management?

The momentum behind non-addictive pain relief solutions is undeniable. As the opioid crisis continues to claim lives, the need for safer alternatives becomes increasingly urgent.

Tonix's commitment to developing the non-addictive TNX-102 SL drug for the chronic pain condition fibromyalgia aligns with growing demand from both patients and regulators for safer options. The active ingredient of TNX-102 SL acts in the brain, which is believed to be the origin of fibromyalgia's nociplastic pain.

In parallel, Vertex's development of VX-458 which acts in the periphery for the acute pain space reinforces the growing momentum for non-opioid solutions across the pain spectrum. As both companies advance their respective treatments, the future of pain management looks increasingly promising, with patients potentially poised to benefit from safer, more effective therapies.

The time has come for new classes of non-addictive painkillers, and Tonix's strategic position with TNX-102 SL potentially places it at the forefront of this critical shift. As the opioid crisis continues to drive demand for safer pain management solutions, Tonix may be set to play a pivotal role in shaping the future of chronic pain treatment.

*TNX-102 SL is an investigational new drug and is not approved for any indication

Featured photo by Gizem Nikomedi on Unsplash

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Investor Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Contact Information

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
862.904.8182

SOURCE: Tonix Pharmaceuticals Holding