This article was originally published on Prohealth.com and is being reprinted here with permission from the editor.
I’ve never had much luck with big pharma’s solutions for fibromyalgia, but I know plenty of fibro warriors whose lives are improved by medications like Lyrica, Cymbalta, Savella, gabapentin and others.
We all wish for that magic pill, so it’s a big deal when pharmaceutical companies announce they’re testing out potential drugs for fibromyalgia.
After all, we are way overdue for new pharmacological treatments. It’s been more than a decade since the U.S. Food & Drug Administration (FDA) approved its last drug for the treatment of fibromyalgia, Savella. That statistic right there is proof of just how perplexing fibromyalgia is for both patients and the pharmaceutical industry.
But four companies are up to the challenge of figuring out the mystery of fibromyalgia and are in the midst of trying to develop new pharmacological options for patients. If successful, several new drugs may hit the market in coming years.
Last June, Aptinyx Inc. announced positive results from a 23-patient, phase 2 study of its novel NMDA receptor modulator, NYX-2925. During the single-blind, placebo-controlled, sequential-designed study, advanced imaging techniques found statistically significant improvements in brain activity biomarkers for central pain processing. Patient-reported pain and other symptom scores were also promising.
According to a press release, there were no serious adverse events reported during the study, and the drug was well tolerated by patients.
“The statistically significant effects on both pain-related brain activity and patient-reported clinical measures elegantly demonstrates that NYX-2925 is acting in the brain to alter pain processing, leading to pain alleviation,” says Norbert Riedel, Ph.D., Aptinyx’s president and CEO. “The results of this study reinforce what we observed in patients with advanced painful diabetic peripheral neuropathy (DPN) in our recent phase 2 DPN study in which NYX-2925 greatly alleviated the centralized pain that is predominant in these patients. The consistency of these data confirms our confidence in advancing NYX-2925 as a treatment for chronic pain.”
Aptinyx plans to recruit fibromyalgia patients for a larger 12-week, randomized, placebo-controlled study of NYX-2925 later this year.
The FDA fast tracked IMC-1, a combination of famciclovir, a common antiviral, and celecoxib, an anti-inflammatory arthritis drug, in early 2016 for a phase 3 trial, but progress has moved at a slug’s pace since then.
For the past two and a half years, IMC-1 has undergone animal studies as required by the FDA to determine potential toxicity.
IMC-1’s parent company Innovative Med Concepts is seeking $30 million from investors to fund the phase 3 human study. If successful, the trial should start early next year, according to Dr. William “Skip” Pridgen, the drug combo’s discoverer.
As a gastrointestinal surgeon, Pridgen is an unlikely source for the next blockbuster fibromyalgia drug. However, his drug combo of an antiviral and an anti-inflammatory addresses a theory that many in the fibromyalgia community have suspected for a long time: Fibromyalgia could be caused by some sort of underlying infection.
In Pridgen’s case, he believes fibromyalgia is triggered by the herpes simplex virus (HSV). IMC-1 works by combining famciclovir and celecoxib, both of which have antiviral properties, to suppress HSV.
(This article gives a more detailed explanation of Pridgen’s theory about the connection between HSV and fibromyalgia.)
Pridgen says he’s successfully used the drug combo in his Tuscaloosa, Alabama, medical practice for years now.
“We’ve treated thousands of patients with this protocol, and every single day I get to witness exactly what this medication does,” Pridgen says. “Once you suppress the virus, it takes [about 12 to 14 weeks] for the immune system to reset and for the body to feel normal. We’re seeing about 90 percent of the patients will get 85 percent better if they follow the protocol precisely.”
Next year’s trial is anticipated to involve between 250 to 500 patients at up to 50 sites around the country.
In 1975, one of the pioneers of fibromyalgia research, Dr. Harvey Moldofsky, was able to induce fibromyalgia-like symptoms in healthy college students by depriving them of deep sleep for several nights. He concluded fibromyalgia (called “fibrositis” back then) should be considered a “non-restorative sleep syndrome.”
That research was some of the early inspiration for TNX-102 SL, a low-dose sublingual version of cyclobenzaprine developed by Tonix Pharmaceuticals Holding Corp. Cyclobenzaprine, sold under the brand name Flexeril, is a commonly used muscle relaxer and sometimes prescribed off label as a treatment for fibromyalgia.
“We think the best way to understand how our drug [TNX-102 SL] is working is by improving sleep quality,” says Dr. Seth Lederman, CEO of Tonix. “Sleep quantity is something that is delivered by Ambien or Lunesta or some of the benzos like Klonopin, but the difference is those drugs … tend to be injurious of high quality sleep. What’s distinctive with our drug and our treatment protocol is we think this medicine improves sleep quality and doesn’t get in the way of some important [activities] that your brain does at night when you’re sleeping.”
Tonix has run into some issues with bringing TNX-102 SL to market for fibromyalgia. TNX-102 SL did not meet its pain-relieving goal in two previous trials when administered to fibromyalgia patients at a dose of 2.8 mg. It seemed like TNX-102 SL was destined for failure like so many other potential fibro drugs before it, but Tonix became hopeful again after a trial of patients with post-traumatic stress disorder reported good results when taking TNX-102 SL at 5.6 mg.
Last April, Tonix was able to get FDA approval to move ahead with a new phase 3 study this fall in which TNX-102 SL will again be administered to fibromyalgia patients – but this time, at a dose of 5.6 mg.
“We did two studies with a dose of 2.8 mg, and in both of those studies, we saw very encouraging evidence across the board,” Lederman says. “We saw it in the daily pain score. We saw it in the Fibromyalgia Impact Questionnaire. We saw it in other measures of fibromyalgia, and in both cases, we narrowly missed the primary endpoint. We think with twice the dose, we’ve got a good shot of getting a better result.”
This fall’s trial is expected to enroll around 500 patients at about 25 sites around the United States.
There’s very little that’s known about Astellas Pharma’s fibromyalgia drug ASP0819 other than the company completed a phase 2, placebo-controlled study last year involving 186 patients. No results or other details have been posted yet on ClinicalTrials.gov.
When asked for more information, Astellas spokesperson Stefanie Prodouz provided the following statement: “ASP0819 is in phase 2 development as an investigational therapy for the treatment of fibromyalgia. We are currently analyzing existing data to determine next steps for the program.”
Now it’s your turn: Are you excited about any of these potential treatments? Share in the comments!