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Tonmya – First New Fibromyalgia Drug in 16 Years, But Questions Remain

picture of single coloured drug in middle of white ones

Tonix Pharmaceuticals has gained FDA approval for Tonmya, the first new fibromyalgia medicine since 2007. Taken under the tongue at bedtime, Tonmya (cyclobenzaprine HCl) is designed to improve non‑restorative sleep which is a core feature of fibromyalgia rather than directly targeting pain.
 
In two Phase 3 trials involving nearly 1,000 patients, it was reported that it modestly outperformed placebo in reducing daily pain after 14 weeks, with more people achieving at least a 30% improvement. Its sublingual delivery may offer faster; more consistent absorption compared with older treatments processed through the liver. Side effects were reported as tolerable within the trials.
 
However, real‑world effectiveness and durability are still unproven. Cyclobenzaprine, the base molecule, has been tried before and shown benefits that faded over time. The FDA approval is based on relatively short studies, so it is unclear how well the drug will work beyond a few months and what it will cost. Experts also note fibromyalgia’s complexity means no single drug helps everyone.
 
While Tonmya offers a welcome new option after a long treatment drought, patients and clinicians may wish to view it as one tool among many, best combined with lifestyle, sleep, and other self-management approaches.

Additionally approval by the FDA in America does not mean it will be approved within the UK. It will require to pass regulatory approval once more before we see it being prescribed by the NHS. 

The active ingredient Cyclobenzaprine was previously available in the UK but is not currently licensed. It has been used previously for fibromyalgia patients. 
 
 
 

Maw's Boutique

**UPDATED STORY***

Turning Pain into Purpose: How One Small Business Owner is Giving Back to the Fibromyalgia Community

Since we last caught up with Mel at MawsBoutique.com, her business has seen exciting growth. Retail sales have continued to rise, and she has now secured a regular wholesale customer, marking a significant milestone in her journey and raising over £200 this past year.

What makes this story truly remarkable isn’t just the business success, but the heart behind it. Her magnesium-based products were created with a very personal mission: to support people living with fibromyalgia. As someone living with the condition herself, she knows first-hand the daily battles it brings.

“I will continue to support the fibromyalgia community as long as I’m able to make these products. I don’t believe in making sales from a condition like this without giving back.”

Read more...

The History of Fibromyalgia

It is International Awareness Day which falls on Florence Nightingales birthday each year. Around the world on May 12th there are events, awareness being raised and activities about increasing the awareness of fibromyalgia.
 
We thought this year as we have been creating a series of video content that we would create one that shows the history of fibromyalgia. Some people think it is a new condition with some dismissing it as a fad or made up. It is not and it is certainly not new. Veterans returning from World War 2 were dismissed as some still are today.

When checking out the videos on our YouTube channel be sure to Like and Subscribe and keep an eye out for new videos.

 

 

Fibromyalgia Awareness

Please share our short video about fibromyalgia to raise more awareness of the condition.

 

Click here if you would like to order a free information pack to any address in the UK.

Adventure Challenges

The Adventure of a Lifetime

Have you ever wanted to trek up Angkor Wat, cycle from London to Paris, or even go Husky sledding in Lapland?

graphic of adventure challenges

Read more...

Fibromyalgia featured on BBC Morning Live

BBC Morning Live featured a good piece on fibromyalgia this morning. It featured Dr Punam speaking about the condition how it affects people, the difficulty in diagnosis and treatment options. Janette Manrara was the presenter and thought the subject was well covered. It had some additional impact as both Jannete and Dr Punam have personal expereince of the condition with their mothers suffering from the condition.

Dr Punam's reflection on the challenges that her mother expereinced many years ago as opposed to our awareness of the condition now was an important aspect. It can be found in iplayer for the next year or so at https://www.bbc.co.uk/iplayer/episode/m001q95f/morning-live-series-5-08092023 and the fibro piece starts at the 23:18 mark till the 28:46 mark.

Thanks to all that took part and helping to raise awareness especially during our awareness week.

Thank you to JManara and Dr Punam for their contribution to the programme. You can find the clip here

More Articles...

  1. View or request our information booklets
  2. Guardian Article - How to move: exercising with fibromyalgia
  3. Harvard Article - CBD for chronic pain: The science doesn’t match the marketing
  4. Jenny Timms: How heat can impact my fibromyalgia
  5. How many times have you heard the advice to “pace yourself?"
  6. FMA UK Statement on Medicinal Cannabis

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