New Medication

Hi Friend

I hope you are doing well. This week I released a short form video around the new medication Tonmya which has got over a million views. It has been hailed as the new fibromyalgia treatment, which is obviously very exciting considering as of yet most medication fail to give patients the relief you deserve. This week I will look deeper into this medication.

How Does Tonmya Work?

Tonmya is a specially formulated, low-dose version of a medicine called cyclobenzaprine — but it’s not mainly used as a muscle relaxant in this case.
Instead, Tonmya is designed to work on the brain and sleep systems that are believed to be broken in fibromyalgia.

Here’s how it works:

• Targeting Sleep and Pain Together:
  In fibromyalgia, scientists have found that people often don’t get enough deep, restorative sleep (especially stages called slow-wave sleep or non-REM sleep). Without deep sleep, the body can’t properly heal, reset pain signals, or manage inflammation.

  Tonmya is taken right at bedtime and is slowly absorbed overnight.
  It helps the brain to calm down and stay in deep sleep longer, without the heavy "knock-out" effect you get from strong sedatives.

• Affecting Key Brain Chemicals:
  Tonmya lightly modulates serotonin and norepinephrine, two brain chemicals that are involved in pain control, mood, and sleep regulation.
  By adjusting these chemical systems gently during sleep, Tonmya may:

  • Reduce abnormal pain sensitivity (called "central sensitization" — a major part of fibromyalgia)

  • Improve sleep depth and continuity (helping you feel more refreshed)

  • Lower daily pain levels over time

• Special Formulation:
  Unlike regular cyclobenzaprine (which wears off quickly and causes lots of grogginess), Tonmya uses a proprietary sublingual tablet — you place it under your tongue, and it slowly melts and enters your bloodstream during the night.
  This method allows a gentler, longer-lasting effect with fewer next-day side effects.

The Research Behind Tonmya for Fibromyalgia

Tonmya has been studied mainly through clinical trials sponsored by Tonix Pharmaceuticals. The biggest study so far is called the RELIEF trial. Here’s what we know:

What Was the RELIEF Trial?

• It was a phase 3 clinical trial, meaning it was a large, late-stage study.

• The study enrolled fibromyalgia patients who were experiencing chronic pain and sleep problems.

• Participants were randomly given either Tonmya or a placebo (sugar pill) at bedtime for 14 weeks.

• The goal was to see if Tonmya could improve sleep and reduce daily fibromyalgia pain better than placebo.

What Did the Results Show?

• Some patients taking Tonmya experienced significant improvements in both pain reduction and better sleep compared to placebo.

• Tonmya was found to enhance restorative sleep (especially non-REM deep sleep), which researchers believe is critical for controlling fibromyalgia symptoms.

• Side effects were generally mild, with the most common ones being drowsiness, dry mouth, and sometimes a bad taste in the mouth — but fewer next-day grogginess problems compared to regular muscle relaxants.

However — and this is important to be honest about — the RELIEF trial did not meet its primary endpoint (the main goal set for the study) with the level of strong statistical proof usually required by the FDA.
But because secondary results (like sleep improvements and reduced pain) looked very promising, Tonix decided to move ahead with a new trial (called the RESILIENT study) to try again with some adjustments.

What’s Happening Now?

• The company launched the RESILIENT phase 3 trial, which is a newer and even more carefully designed study.

• They are adjusting the way they measure outcomes to better capture the benefits that patients actually feel — especially improvements in sleep quality and daily functioning.

• Tonix hopes that if the RESILIENT trial succeeds, Tonmya could be submitted to the FDA for approval as a fibromyalgia treatment.

The latest results from the RESILIENT Phase 3 trial for Tonmya (also known as TNX-102 SL) were released on December 20, 2023. This trial demonstrated statistically significant improvements in daily pain reduction, sleep quality, fatigue, and overall fibromyalgia symptoms compared to placebo. ​

Following these positive outcomes, Tonix Pharmaceuticals plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024. A pre-NDA meeting with the FDA was scheduled for the second quarter of 2024. ​

If the FDA review proceeds as anticipated, a decision regarding the approval of Tonmya for the management of fibromyalgia is expected in the second half of 2025. Hopefully the UK and NICE will follow!

I know we have been here before, with so many promising treatments coming and going. Then the question is if it does really help, will it only be available as a private med or will it be on the nhs and for everyone? That all being said Like you all I am so glad that there is active research going into helping this very debilitating disease that needs more awareness.

As always I will keep you updated on any news on this. I have had so many people reach out to try and help from, scientists, researchers, and we are trying to organise our own large scale study around the causes and factors around fibromyalgia (stay tuned, details soon). I will be doing another webinar next week and I will send the link out to you. The fibromyalgia community is n the final stages of being ready to go, I will be opening this for free to some readers to test it and see how I can make it before before the main launch.

As always, if any questions please let me know,

Yours faithfully

Dr Ahmed