Tonix Pharmaceuticals Advances Non-Opioid Fibromyalgia Treatment, Tonmya, Toward Market Entry
TL;DR
Tonix Pharmaceuticals aims to disrupt the fibromyalgia prescription market dominated by opioids, positioning Tonmya as a non-opioid alternative.
Tonmya offers a non-opioid therapy for fibromyalgia, addressing the risks of dependency and showing promising interest from physicians.
Tonmya's potential approval could provide a safer, non-addictive option for fibromyalgia patients, improving access with the Inflation Reduction Act.
Tonmya represents a groundbreaking first-line therapy for fibromyalgia, offering a safer, non-addictive alternative in a market dominated by opioids.
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Tonix Pharmaceuticals CEO Dr. Seth Lederman recently announced the completion of the initial phase of an assessment by EVERSANA® Life Science Services, LLC on the U.S. market opportunity for Tonmya, a potential groundbreaking first-line therapy for fibromyalgia management. Tonmya is positioned as a non-opioid, centrally-acting alternative in a market currently dominated by opioids.
Dr. Lederman emphasized the concerning prevalence of opioids in the fibromyalgia prescription market, despite the well-documented risks of dependency associated with these drugs. Tonmya aims to fill this critical gap by offering a safer, non-addictive option for patients suffering from fibromyalgia, a chronic condition characterized by widespread musculoskeletal pain, fatigue, and tenderness in localized areas.
According to EVERSANA's primary market research, there is promising interest from physicians in the adoption of Tonmya, with a median interest rating of 4.0 on a 5-point scale. Additionally, the research indicates that physicians intend to use Tonmya in approximately 40% of fibromyalgia patients upon its approval. This high level of interest underscores the demand for safer alternatives to opioid treatments.
The analysis also noted that around 50% of fibromyalgia patients in the U.S. are on Medicare. This demographic could particularly benefit from the Inflation Reduction Act, which will cap out-of-pocket prescription drug costs for Medicare patients starting in 2025. This legislation could significantly improve access to Tonmya if it receives FDA approval, making it a more affordable option for many patients who rely on Medicare for their healthcare needs.
Tonix Pharmaceuticals has planned the submission of the New Drug Application (NDA) for Tonmya in the second half of the year. The company anticipates an FDA decision on the approval of Tonmya by 2025. If approved, Tonmya could revolutionize the treatment landscape for fibromyalgia, offering a much-needed alternative to current opioid-based therapies.
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