FDA acceptance propels Tonix Pharmaceuticals’ TNX-102 SL towards fibromyalgia treatment approval

Tonix Pharmaceuticals Holding Corp. has achieved a pivotal milestone with the FDA acceptance announcement for its New Drug Application (NDA) of TNX-102 SL, a novel treatment for fibromyalgia. This non-opioid, centrally acting analgesic is designed specifically to address the unmet needs of over 10 million U.S. adults suffering from the condition. With fibromyalgia patients lacking new therapies for more than 15 years, the approval of TNX-102 SL could transform the treatment landscape.

What Makes TNX-102 SL Unique For Fibromyalgia Treatment?

TNX-102 SL is a sublingual formulation of cyclobenzaprine hydrochloride, specifically developed for bedtime use to target non-restorative sleep, a common symptom among fibromyalgia patients. Unlike traditional oral cyclobenzaprine, the sublingual route bypasses first-pass metabolism, leading to faster absorption and improved therapeutic action. This formulation is believed to enhance the management of fibromyalgia by addressing central sensitisation, the underlying mechanism of the condition.

Tonix Pharmaceuticals highlighted that TNX-102 SL, if approved, would mark the first drug in a new class of fibromyalgia treatments. Seth Lederman, Chief Executive Officer of Tonix Pharmaceuticals, underscored the importance of the FDA acceptance announcement, describing it as a major advancement in bringing a non-addictive, effective treatment to patients who often rely on opioids or outdated therapies.

The Journey To FDA Acceptance

The new drug application for TNX-102 SL is supported by robust data from two pivotal Phase 3 clinical trials: RELIEF and RESILIENT. Both studies demonstrated statistically significant reductions in daily pain among fibromyalgia patients, compared to placebo.

In the RELIEF trial, TNX-102 SL achieved its primary endpoint, significantly reducing patient-reported pain scores over 14 weeks.

The RESILIENT trial reaffirmed these results, with even greater statistical significance.

In both trials, TNX-102 SL demonstrated excellent tolerability. The most common adverse effect, temporary tongue numbness at the site of administration, was mild, self-limited, and rarely led to discontinuation. Tonix Pharmaceuticals stated that systemic adverse events were infrequent, with rates lower than 4.0%. These findings underscore the drug’s potential to become a safer and more targeted fibromyalgia treatment option.

Why Fibromyalgia Patients Need Better Treatment Options

Fibromyalgia is a chronic pain disorder characterised by widespread musculoskeletal pain, fatigue, cognitive dysfunction (often referred to as “brain fog”), and sleep disturbances. The condition, which primarily affects women, significantly impairs daily functioning and quality of life. Current treatment options include FDA-approved drugs that have limited efficacy, leaving many patients dissatisfied.

Additionally, insurance claims data, commissioned by Tonix Pharmaceuticals, reveal concerning trends. Within 18 months of diagnosis, fibromyalgia patients were more likely to be prescribed addictive opioids than all three FDA-approved therapies combined. This underscores the urgency for innovative, safer therapies like TNX-102 SL to achieve fibromyalgia treatment approval.

What’s Next In The FDA Review Process?

The FDA is expected to assign a Prescription Drug User Fee Act (PDUFA) target action date in its upcoming Day 74 Letter, which will also confirm whether TNX-102 SL qualifies for Priority Review. Fast Track designation, granted in July 2024, has already accelerated the NDA submission process, reflecting the critical need for this treatment.

Tonix Pharmaceuticals anticipates potential FDA approval in 2025, positioning TNX-102 SL to address a significant therapeutic gap for fibromyalgia patients. Lederman expressed confidence in the drug’s ability to redefine fibromyalgia care, offering a non-opioid alternative for fibromyalgia management.

The Broader Impact Of TNX-102 SL’s Approval

If approved, TNX-102 SL will be the first new drug application for fibromyalgia in over a decade and a half. This milestone could not only improve treatment outcomes but also reduce reliance on opioids, contributing to broader public health efforts to combat opioid misuse.

Moreover, the approval would solidify Tonix Pharmaceuticals’ position as a leader in pain management innovation. The company has already initiated commercial preparations, leveraging its experienced leadership team to ensure a smooth market launch.

A New Era For Fibromyalgia Patients

The FDA acceptance announcement for TNX-102 SL marks a promising step toward addressing the unmet needs of millions of fibromyalgia sufferers. With its unique mechanism of action, proven efficacy, and strong safety profile, TNX-102 SL has the potential to revolutionise the way fibromyalgia is treated.

As the FDA review progresses, fibromyalgia patients, healthcare providers, and advocates alike will be closely watching this breakthrough therapy. For those who have struggled with chronic pain, sleep disruptions, and limited treatment options, TNX-102 SL could represent a long-awaited turning point.