New drug

Posted by cooper78 @cooper78, Aug 28 3:07pm

I have just learned of FDA approval of Tonmya for fibromyalgia. Will be eager to learn more!

Interested in more discussions like this? Go to the Fibromyalgia Support Group.

Profile picture for daisy17 @daisy17

This new drug is nothing more than cyclobenzaprine (aka Flexeril) that has been reformulated to be a lower dose and taken subliminally rather than as a pill you swallow. By reformulating the drug, the drug company can charge lots more money. (I take a 5mg tablet of cyclobenzaprine before bed. I think it helps with sleep and pain.)

An article by Pradeep Chopra, MD (a Harvard-trained pain medicine specialist with over 25 years of experience treating complex chronic pain and multisystem disorders.) has this Summary: "In summary, sublingual cyclobenzaprine (Tonmya) is essentially a repackaged low‑dose formulation of cyclobenzaprine, marketed as a novel drug through its patented delivery system. Its pharmacokinetic differences are small, its clinical benefit is modest and comparable to existing oral formulations, and its unique adverse effects may outweigh the theoretical advantage of reduced metabolite formation. Clinicians should therefore critically evaluate manufacturer claims and consider whether simple, low‑dose oral cyclobenzaprine would provide equivalent benefit at far lower cost.

In summary, the report concludes that Tonmya’s sublingual delivery offers only minor pharmacokinetic differences compared to oral cyclobenzaprine. Despite claims of reduced metabolite formation, the active metabolite norcyclobenzaprine remains pharmacologically relevant and may contribute to therapeutic effects. The analysis shows that dosing, rather than delivery route, largely explains any variation in drug exposure. It highlights that low-dose oral cyclobenzaprine already achieves similar outcomes and underscores that Tonmya’s modest pain reduction and unique oral adverse effects do not justify its higher cost or novelty. The conclusion advises clinicians to weigh claims critically and consider low-dose oral formulations as cost-effective alternatives."

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Thanks for posting this. It is very informative and helpful.

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Profile picture for cooper78 @cooper78

That’s great! I have now learned that new drug, Tonmya, is same as flexeril. Maybe some minor changes I suppose!

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Good to know
Thanks!

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I really hate new medications especially if they are just old junk wrapped up again with an expensive price.

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Old stuff is better because we know what we are getting. I ask my doctor for medication that is off patttent . I went against this with Emgaliy and I am very sorry I did that.

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Profile picture for daisy17 @daisy17

This new drug is nothing more than cyclobenzaprine (aka Flexeril) that has been reformulated to be a lower dose and taken subliminally rather than as a pill you swallow. By reformulating the drug, the drug company can charge lots more money. (I take a 5mg tablet of cyclobenzaprine before bed. I think it helps with sleep and pain.)

An article by Pradeep Chopra, MD (a Harvard-trained pain medicine specialist with over 25 years of experience treating complex chronic pain and multisystem disorders.) has this Summary: "In summary, sublingual cyclobenzaprine (Tonmya) is essentially a repackaged low‑dose formulation of cyclobenzaprine, marketed as a novel drug through its patented delivery system. Its pharmacokinetic differences are small, its clinical benefit is modest and comparable to existing oral formulations, and its unique adverse effects may outweigh the theoretical advantage of reduced metabolite formation. Clinicians should therefore critically evaluate manufacturer claims and consider whether simple, low‑dose oral cyclobenzaprine would provide equivalent benefit at far lower cost.

In summary, the report concludes that Tonmya’s sublingual delivery offers only minor pharmacokinetic differences compared to oral cyclobenzaprine. Despite claims of reduced metabolite formation, the active metabolite norcyclobenzaprine remains pharmacologically relevant and may contribute to therapeutic effects. The analysis shows that dosing, rather than delivery route, largely explains any variation in drug exposure. It highlights that low-dose oral cyclobenzaprine already achieves similar outcomes and underscores that Tonmya’s modest pain reduction and unique oral adverse effects do not justify its higher cost or novelty. The conclusion advises clinicians to weigh claims critically and consider low-dose oral formulations as cost-effective alternatives."

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I was given flexeril for a sleep disorder and was told to take 1/2 of a 5mg tablet nightly. It worked but I have a fear of dependence as I’m a recovering addict and, while “downers” weren’t my issue, as one addict said in a meeting, “I can become addicted to a glass of water.”
The flexeril helped a little with my fibro body pain but not so much that it outweighed any concern I had over dependence. I take 2.5 mg of melatonin as needed to help me stay asleep now, and I found a chewable. (I take enough pills a day. I hate adding another.)

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Me aswell! I am hoping and praying that it helps me and others who deal with Fibromyalgia.

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