FDA Approves Generic Duloxetine for Fibromyalgia-associated Pain and Depression

FDA Approves Generic Duloxetine for Fibromyalgia-associated Pain and Depression

The U.S. Food and Drug Administration has approved Duloxetine, a generic version of Cymbalta (duloxetine), for treating fibromyalgia, depression, and anxiety, according to the generic’s maker, Solco Healthcare U.S.

In addition to fibromyalgia, Duloxetine, the active ingredient in Cymbalta, is used to treat serious depression in adults, and anxiety in adults and children 7 years and older.

Scientists say Duloxetine works by increasing levels of the neurotransmitters serotonin and noradrenaline in the nervous system.

“We are pleased to receive this FDA approval, which adds to our growing line of central nervous system acting agents,” Hai Wang, president of Solco Healthcare, said in a press release. “We continue to strengthen our presence within the U.S. generic market by providing high-quality medicines at affordable prices.”

Time-released Duloxetine capsules are available in three formulations: 20, 30 and 60 mg.

Hallmarks of fibromyalgia include chronic musculoskeletal pain, extreme fatigue, and sleep and mood disturbances. Patients can also experience psychological distress, including depression and anxiety. They often use antidepressants to help cope with these problems.

Previous studies have shown that duloxetine benefits fibromyalgia patients.

In a clinical trial, researchers at the University of Turin in Italy compared duloxetine’s benefits in fibromyalgia patients with those of the depression treatment acetyl L-carnitine.

Both duloxetine and acetyl L-carnitine reduced depression and pain, and improved patients’ physical quality of life. But only duloxetine improved patients’ psychological quality of life.

A Phase 3 clinical trial in Japan (NCT01552057) assessed duloxetine’s safety and effectiveness in 393 people with fibromyalgia. The patients were randomly assigned to receive either duloxetine or a placebo  once a day for 14 weeks.

Duloxetine did a significantly better job than a placebo in relieving fibromyalgia patients’ pain and improving both their other symptoms and quality of life. It was also safe, and patients tolerated it well.

Fibromyalgia affects an estimated 5 million to 15 million Americans, especially women. Experts say there is a pressing need for therapies to address the many facets of the disease.

7 comments

  1. Karen says:

    A few years ago I was on Cymbalta. My body tolerated it well for a few months but then I started excessive sweating. I also had brain zaps that felt like fireworks in my brain. I read about Cymbalta & decided to ask my dr to help wean me off of it. Not sure if it is a safe drug to be on?

  2. Peter says:

    Hasn’t duloxetine already been made generic a long time ago by Apotex? Is this story news because the price will go down or just because Solco sent out a press release? I don’t see any mention of Apotex in their materials.

  3. Brian Carland says:

    While the pain reducing benefit of duloxetine in fibromyalgia is undisputed, potential patients should be aware of the “discontinuation syndrome” associated with the drug. I’ve taken duloxetine for over ten years for my fibro and find it lowers pain by 50% or more, but even a day without my dose produces sensations of electric current running through my spine and brain, dizziness, mood change (anger), and loss of mental concentration.

    In short, once you start you may not be able to quit. Weigh the benefit against the risk of dependence very carefully.

  4. Janice says:

    I can’t say I’ve ever met anyone who has improved with Cymbalta or any of the other so called FM drugs. In fact, those who have used or are using these have deteriorated.
    More emphasis should be placed on food/diet. After 16 years, I have discovered a great deal of interaction with foods for FM, especially sugar. Drugs, particularly those in anyway related to anti-depressants should be fully investigated. These are habit forming drugs and withdrawal is a serious consideration.

    • Angelika Tetzlaff says:

      Amen! I have much better control of managing both pain & anxiety now that I am off of all Pharma meds. Food, Vitamins, Supplements, essential oils, teas & my 2 favorite herbs Cannabis & Kratom have given me back the hope that was all but lost as I used to lay curled up in the fetal position praying that God would take me home.

    • Peter says:

      Janice, even in these comments you can see that some of us have experienced benefits from duloxetine — and continue to use it despite its serious complications. Clearly it’s not helpful or suitable for everyone. But, since the bulk of the body’s serotonin storage is overwhelmingly located in the digestive system, certain etiologies of FM are more likely to suggest a duloxetine trial.

      With my small-fiber neuropathy and decades of IBS, I found duloxetine dramatically improved my overall burning and IBS within days. After about six years of 90mg/day, I weaned down to 60 this year, but this took about six months to achieve. The burning, IBS, and some other symptoms have worsened in that time, but I’m looking for a balance, trading off some comfort for fewer side effects. Maybe some day I’ll wean completely, but that’ll probably require finding some other combo of meds/supplements to take its place. Full-force FM, for me, is akin to having the flu. Duloxetine has largely mitigated that.

  5. Robin Paur says:

    As a patient who has been on Duloxetine for fibromyalgia for at least 15 years, I can tell you that while the benefits of the medication last for a while (I cannot quantify, as I have just finished a rather painful tapering-off procedure), I am looking forward to trying a different medication. Duloxetine has a short beneficial life, as far as pain treatment goes as far as I am concerned, and I am very happy to be off of it.

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