Tonix Pharma Reveals Key Phase One Findings of EVERSANA Analysis on Tonmya™ for Fibromyalgia

Tonmya, a new non-opioid analgesic designed for fibromyalgia management, has shown promising results in clinical trials, raising significant interest among primary care physicians. Recent research by EVERSANA® Life Science Services, LLC, a prominent provider of commercialization services in the life sciences industry, assessed the U.S. market potential for Tonmya (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets). This collaboration aims to strategize an effective market launch for Tonmya, planned for 2025.

Tonmya has demonstrated strong efficacy through two Phase 3 clinical trials. These trials showed significant improvements in daily pain reduction, sleep quality, fatigue, and overall symptoms of fibromyalgia compared to a placebo. The medication is taken sublingually at bedtime and operates as a centrally acting agent without resorting to opioids.

Research indicates a substantial unmet need in fibromyalgia treatments. According to surveys, a high level of dissatisfaction exists with current FDA-approved fibromyalgia medications, such as Duloxetine, Pregabalin, and Savella. Many patients find these treatments insufficient due to limited efficacy and tolerability. In contrast, Tonmya has garnered considerable interest from physicians, who rated their interest at 4.0 on a 5-point scale. They indicated that, upon approval, they would potentially prescribe Tonmya to 40% of their fibromyalgia patients.

The market analysis by EVERSANA revealed that approximately 2.7 million adults in the U.S. are currently diagnosed and treated for fibromyalgia, with about 90% of these patients being female. Despite the availability of FDA-approved drugs, there is a notable trend of prescribing addictive opioids more frequently than these approved medications post-diagnosis. This highlights a critical need for alternative therapies like Tonmya that can address pain without the risks associated with opioids.

The research also showed that many patients who fail first-line therapy often resort to off-label drugs such as Gabapentin, Hydrocodone, Oxycodone, Tramadol, Meloxicam, and Amitriptyline. The high prevalence of opioid prescriptions, including Hydrocodone, Oxycodone, and Tramadol, underscores the dependency risks that Tonmya could potentially mitigate.

Tonmya's launch strategy will target high prescribers, including rheumatologists, pain medicine specialists, primary care physicians, neurologists, and psychiatrists. Notably, around 50% of diagnosed fibromyalgia patients are covered by Medicare. The upcoming changes from the Inflation Reduction Act in 2025, which will cap out-of-pocket prescription drug costs to $2,000 annually, could further benefit this population.

Tonix Pharmaceuticals, the company behind Tonmya, has announced plans to submit a New Drug Application (NDA) to the FDA in the second half of 2024. This follows the positive outcomes of the Phase 3 trials, which showed statistically significant improvements in pain and other symptoms of fibromyalgia. Tonix has also scheduled a Type B pre-NDA meeting with the FDA for the second quarter of 2024 to discuss the submission.

Tonmya represents a potentially transformative addition to fibromyalgia treatment options, offering a non-opioid alternative that addresses the core symptoms effectively. As dissatisfaction with current treatments remains high, Tonmya’s introduction could significantly impact patient care and reduce reliance on opioids, aligning with the growing demand for safer, more effective fibromyalgia therapies.