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FDA Approves Tonmya: First Fibromyalgia Treatment in 15 Years

8/19/2025

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Summary

Story summary

The FDA approved Tonmya, the first fibromyalgia treatment in over 15 years, from Tonix Pharmaceuticals.
Fibromyalgia impacts approximately 10 million adults in the U.S., mainly women.
Tonmya is a non-opioid analgesic for once-daily use, featuring rapid absorption.
Approval followed two Phase III trials with over 1,000 participants, demonstrating significant pain reduction.
Tonmya is expected to be available to patients by late 2025.

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Story summary

The FDA approved Tonmya, the first fibromyalgia treatment in over 15 years, from Tonix Pharmaceuticals.
Fibromyalgia impacts approximately 10 million adults in the U.S., mainly women.
Tonmya is a non-opioid analgesic for once-daily use, featuring rapid absorption.
Approval followed two Phase III trials with over 1,000 participants, demonstrating significant pain reduction.
Tonmya is expected to be available to patients by late 2025.