A Tuscaloosa organization which is developing a progressive way to deal crippling infection is approaching its last preliminaries. Creative Med Concepts is getting ready for one of two last FDA preliminaries for what it has named IMC-1, a medication that in earlier tests has demonstrated critical adequacy in battling the impacts of fibromyalgia and fibromyalgia treatment.
Tuscaloosa specialist Dr. William “Skip” Pridgen of Tuscaloosa Surgical Associates is the CEO of Innovative Med Concepts, an organization was established in 2012 after his discovery that blend of two existing medications was profoundly affecting sufferers of fibromyalgia and irritable bowel syndrome.
“The two medicines together do something that individually the components would never do,” Pridgen said.
In this randomized, twofold blinded, fake treatment controlled, verification of-idea study, the medication was assessed for its adequacy and security. A total of 143 female members with FM, from various locales over the U.S., got either IMC-1 or a fake treatment. Analysts estimated the members’ torment scores over a 16-week fibromyalgia treatment period utilizing two polls: The Patient Global Impression of Change (PGIC), and the reexamined infection explicit Fibromyalgia Impact Questionnaire (FIQ-R).
Results, first declared at the 2014 American College of Rheumatology yearly gathering and distributed in the Journal of Pain Research, demonstrated that after the 16-week treatment period, patients taking ICM-1 had a reduction in fibromyalgia-related torment, and improved scores on the two surveys. There additionally was an abatement in patients’ self-detailed weariness levels. The medication was well-endured and safe for fibromyalgia treatment.
This restorative formula, a particular mix of famciclovir and celecoxib, has now been licensed and exposed to various FDA-required preliminaries.
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In the latest preliminary Pridgen demonstrated that IMC-1 gave more prominent agony and relief than any other fibromyalgia treatment or painkiller prescriptions available right now, including Lyrica and OxyContin, while more patients taking a fake treatment announced undesirable symptoms and in this way dropped out of the research, than those on the drug itself.
“It had a huge signal, meaning it was affecting everything,” Pridgen said, clarifying that IMC-1 was assisting with reducing torment, pain, depression and fatigue, among different indications directly related with fibromyalgia and the death toll from the drug overdoses only in 2018 was 68000, IMC-1 is achieving this degree of accomplishment without being a narcotic or opiate that is powerless to mishandle and overdose.
Pridgen said, “We’re fixing the underlying problem, we’re not just trying to mask the pain.”
It took until 2007 for the main medication to be made whereas guidelines for diagnosing and treating fibromyalgia weren’t developed until 1990. Pridgen said the about 8 million to 10 million Americans who are experiencing the condition a large portion of whom are ladies with a normal age of 49 feel like they’re continually “being pursued by a tiger”, as the body’s immune system works nonstop to battle a typical and torpid infection that is presently stimulated.
Pridgen proposed that it is activated by dynamic herpes infections inside the intestinal tract. He stated that this virus is present in all of us yet, a distressing circumstance – a separation, an unexpected or agonizing passing in the family becomes a cause of actuating the infection and driving the body to attack it.
With each fruitful preliminary of ICM-1, a significant number of the secrets encompassing the reasons for fibromyalgia are being expelled as Pridgen’s hypotheses demonstrate to be right.
“What we’ve done is clarified so much that was cloudy in the past,” Pridgen said.
According to Pridgen estimate it will take at least $48 million to $50 million to fully complete the tests, FDA approval and get the drug on the market. But it is far less than the $560 million that is a typical cost to introduce a new drug.
IMC is hosting a meeting with potential investors at the end of this month and Pridgen also mentioned the company also has been in negotiations with pharmaceutical companies and investment banks about licensing or buying IMC when IMC-1 is cleared for medical use by the FDA.
According to the early reports the drug will be introduced to the market in 2023 until then the research on the IMC-1 continues on fibromyalgia treatment.
“It’s really remarkable. It doesn’t work on everyone, but it works on most everyone, But I feel like we can see the light at the end of the tunnel and this is going to happen.” Pridgen said.
Also Read: Hope for millions with fibromyalgia as new gut bacteria test could diagnose condition faster
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References: Tuscaloosa company nears finish line for new fibromyalgia drug By Jason Morton via Tuscaloosa News
Fibromyalgia and Herpes Virus by Naomi Prex Arbaa,MD via Fibromyalgia Resources
