By Donna Gregory Burch
A general surgeon with a small practice in Tuscaloosa, Alabama, Dr. William “Skip” Pridgen admits he’s an unlikely creator for the next blockbuster fibromyalgia drug.
But the U.S. Food and Drug Administration (FDA) has fast tracked Pridgen’s novel pairing of famciclovir (Famvir), a common antiviral, with celecoxib (Celebrex), an anti-inflammatory arthritis drug, for a phase III trial next year. Based on data from a 2014 phase II trial, the combo known as IMC-1 could give some stiff competition to Lyrica and Cymbalta, two of the most profitable drugs prescribed for fibromyalgia.
Like so many discoveries, Pridgen’s was accidental. He’d been treating patients with chronic gastrointestinal conditions for years and started to notice a pattern: Their symptoms would wax and wane over time, increasing whenever patients would become overly stressed. Pridgen’s mother is a virologist, and the pair speculated the stressors could be activating a virus, which in turn aggravated gastrointestinal and other symptoms. He’s concluded the HSV1 virus, commonly associated with cold sores, may be a culprit in fibromyalgia.
“Many herpes viruses are known to significantly upregulate COX enzymes in the body, which in turn are important for efficient viral replication,” he explained in a media release. “In theory, physical or emotional stress in patients can reactivate the virus and result in perpetuation of the symptoms of fibromyalgia. Effectively suppressing latent viruses may significantly improve the pain and related symptoms of fibromyalgia.”
But almost everyone on the planet has been exposed to the HSV1 virus. So, why do some people develop fibromyalgia while others do not?
“There’s a group of people who are genetically damaged in a way,” Pridgen explained. “There’s something that’s wrong with the immune system such that most people can force the virus to go into dormancy. These patients can’t.”
Pridgen thinks the virus remains active in the gastrointestinal tract and possibly in the sinuses and pelvic region as well.
“The body thinks there’s an ongoing war 24/7; everything gets amplified,” he said.
(This story gives a more technical synopsis of Pridgen’s theory about the connection between HSV1 and fibromyalgia.
Years ago, Pridgen began testing his HSV1 theory by offering antiviral medications to fibromyalgia patients whose symptoms alternated over time, and they reported some minor improvements in functioning. These same patients often complained about their chronic pain, and he began giving samples of Celebrex, an anti-inflammatory commonly prescribed for arthritis, to see if it might help.
He noticed those who received the combination of an antiviral and Celebrex dramatically improved over time. They not only reported a decrease in their gastrointestinal issues, but they also had less pain, fatigue, headaches and other symptoms commonly associated with fibromyalgia. Pridgen realized he might be onto something, and so did his patients. Word of mouth spread, and more fibromyalgia patients began coming to his practice.
“It really was just the planets aligning for me,” he says. “I knew each drug alone didn’t do a whole lot, but when given together, they did something remarkable.”
In 2014, Pridgen’s biotech company, Innovative Med Concepts, released data from its phase II trial involving 143 fibromyalgia patients treated at 12 U.S. clinics. The patients either took IMC-1 or a placebo for 16 weeks.
“We had pain reduction levels that rivaled or were comparable to other fibromyalgia drugs,” Pridgen said. “It wasn’t just that we reduced their pain. In all the measures we looked at [including fatigue, anxiety, headaches, TMJ, etc.], we seem to have an impact overall.
“We’re radically different [from other fibromyalgia drugs],” Pridgen continued. “Instead of just trying to reduce pain perception, we think we’ve discovered what is at the root cause [of fibromyalgia].”
Carol Duffy, associate professor of biological sciences at University of Alabama at Tuscaloosa, began partnering with Pridgen on his research in 2011. She believes IMC-1 works because it’s hitting HSV1 on two fronts: Famciclovir keeps the virus from replicating, and celecoxib stops reactivation and replication.
“When he gives them the meds, those fibro-like symptoms of widespread pain [and] fatigue, seem to go away, but it takes a while. It usually takes two months of being on the meds. … I think it’s much better than narcotics as far as treating symptoms. I feel like it’s treating it further up the line than narcotics.”
Annie George, a 22-year-old college student from Boston, is one of Pridgen’s success stories. She was diagnosed with fibromyalgia in high school and has tried numerous pharmaceutical treatments over the years. None of them helped, and most caused bad side effects.
When she first started seeing Pridgen in 2014, she was struggling to complete her undergraduate degree in engineering. She’d landed in the hospital several times with unexplained fevers, severe stomach pain and other symptoms. Her fatigue was so debilitating that she’d get up in the morning, take a shower, eat breakfast and then have to take a nap before she could attend classes. After a two-hour class, she’d come home and sleep for 12 hours, only to wake up exhausted again.
“I basically gave up all hope of living a normal life, of wanting to be a doctor, of wanting to be an independent person,” George said.
George and her mother flew to Tuscaloosa to meet with Pridgen after reading about his promising drug combo. She’s been on IMC-1 for about a year now, and it’s changed her life.
“Within two months, I started noticing a very big difference,” she said. “I could go to class and not get a fever. I could be out of the house for eight hours straight, which I hadn’t done since high school. I could do more, and the pain is just a lot less.”
She’s pain free most days, and her fatigue is nearly gone. George is working on her master’s degree and applying to medical school.
“It’s a day and night difference,” she said. “I’m not even the same person. I’m actually a normal 22-year-old girl.”
Like every fibromyalgia treatment, IMC-1 doesn’t work for everyone. Phase II results showed 37.9 percent of patients reported a 50 percent or greater reduction in pain after 16 weeks of treatment. That’s slightly better than Cymbalta, the most effective of the three FDA-approved fibromyalgia drugs.
Side effects were low, with more patients from the placebo group dropping out of the trial due to adverse reactions than those taking IMC-1.
Pridgen expects even better results from next year’s phase III trial because it will use the dosage he’s been perfecting in his practice for the past six years. Phase II used a lower, less effective dose.
Phase III may enroll up to 1200 patients at around 60 sites, some of which could be international. Several major pharmaceutical companies have already expressed interest in IMC-1, and a new drug could be on the market within three years.
Pridgen thinks the combo might also benefit patients with ME/CFS and irritable bowel syndrome, and trials are tentatively planned for those conditions.
More information about IMC-1 can be found on Innovative Med Concepts’ website.
Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained pain, fatigue and other symptoms. She covers news, treatments, research and practical tips for living better with fibromyalgia on her blog, FedUpwithFatigue.com. Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.