The probability of treating fibromyalgia with psychedelics in the nearest future has significantly increased following Silo Pharma Inc's latest announcement about its novel psychedelic compound, which is still in its developmental stage. The reputable pharmaceutical company has begun dosing its newest formulation of Ketamine SP-26, which will be used topically to cure or manage fibromyalgia.
The research team at Silo, the fast-rising developmental-stage psychedelics biotech company, also specified that they would use an IND-enabling study of proprietary time releases while administering the compound during this safety trial.
Overview of Fibromyalgia
Fibromyalgia is one of many disease conditions that affect the nervous system and result in chronic pain or fatigue. Patients who have Fibromyalgia often experience widespread tenderness and ranging levels of pain in their muscles, joints, and other areas of their bodies. Medical researchers and practitioners have explained that Fibromyalgia is not an autoimmune disease; however, they are yet to understand the underlying cause of the complex condition fully.
Fibromyalgia is often confused with Multiple Sclerosis because they possess similar symptoms like muscle weaknesses; however, they are different disease conditions. For instance, Fibromyalgia pain could range from a dull ache to a cascading pain and can be accompanied by tender muscle or tendon spots. Other unique symptoms include restless leg syndrome, chronic fatigue, and fibro fog, otherwise known as a sense of confusion. Before a patient can be officially diagnosed with fibromyalgia, they must have exhibited most of these symptoms for at least three months.
At the time of writing, Fibromyalgia remains a long-term condition with no cure but can be managed with specific medications. These medications help to reduce the patient's symptoms and improve their general quality of life. According to the American College of Rheumatology, the best methods for managing Fibromyalgia include medical therapy, physical exercises, mental health support, and enough sleep. The latest lift of restrictions on psychedelics has more or less positioned psychedelic compounds as an alternative way to treat Fibromyalgia. And Silo has taken up this challenge.
Silo's Latest Efforts
In their recent publication, Silo disclosed that the proposed safety evaluation trial to test the suitability of its just-developed novel psychedelic compound would be carried out by a renowned frontage company known as Experimur. The trial will assess the tolerability of SP-26 to determine the right amount of dose that can be administered to a patient. The trial will establish the minimum and maximum dose for a Fibromyalgia patient.
Seeing as the chronic medical condition also causes sleep difficulties, memory loss, and widespread musculoskeletal pain, the team seeks to determine the standard dose administration that can reduce the symptoms and improve the patient's quality of life.
Eric Weisblum, CEO of Silo Pharmaceuticals Inc, stated in an interview that the company is more than excited to cross this milestone. He acknowledged their partner, Zulo therapeutics, a South Carolina pharma, for working successfully with them till this point. He further spoke of how both companies have successfully developed a new method to efficiently deliver the psychedelic formulation, ketamine, via a time-released sequence. He noted that the novel drug showed a superior ability to reduce neuropathic nerve pains during the project's pre-clinical studies.
According to Eric, this IND-backed study will help bring the research team closer to testing the novel formulation in real-life fibromyalgia patients.
It is worth noting that Silo Pharma and its regulatory partner are moving forward with their plans to register a pre-investigational New Drug (IND) package submission SP-26 to the FDA via the 505(b)(2) regulatory pathway. This request specified one or more clinical or nonclinical studies that are required for approval but have not yet been completed by the applicant and for which the applicant lacks the right of reference.
Psychedelics: The Future of Fibromyalgia therapy?
The market for fibromyalgia therapies was estimated by Fortune Business Insights to be worth $764 million in 2020 and $1.4 billion in 2027, with a Compound Annual Growth Rate (CAGR) of 9.2% within the next five years. This shows a massive market for psychedelic producers to fill and profit from while improving thousands of lives.
To some patients, using psychedelics for fibromyalgia may seem weird, but with the development from Silo researchers and others, it's becoming more apparent that these compounds may help. The FDA may soon allow psychedelic medications like psilocybin and NMDA, according to several researchers.
The Chronic Pain & Fatigue Research Center at the University of Michigan, which has unparalleled experience evaluating treatments for fibromyalgia and other chronic pain indications, explained that nothing is more important to their team than developing psychedelic and psilocybin therapies that will address the daily distress of patients.
In a similar trial to the Silo team’s proposed research, the research center evaluated the safety and efficacy of Tryp's TRYP-8802 oral formulation of synthetic psilocybin. The treatment also included psychotherapy to address pain through neuroplasticity, which alters and reorganizes neural networks in the brain. At the time, Tryp President and Chief Science Officer Jim Gilligan told the media that he was thrilled to work with other forward-thinking doctors and scientists to provide alternative treatments for common painful conditions like fibromyalgia and multiple sclerosis.
Last year, another pharmaceutical company, Mind Medicine (MindMed), announced plans to study LSD as a treatment for cluster headaches and an unidentified "common, sometimes devastating, chronic pain condition."
For companies like Silo and Tryp, their objective is to develop psilocybin-based medications to meet unmet medical demands for the treatment of diverse diseases like chronic pain/fatigue and eating problems.
Bottom Line
Fibromyalgia leaves people with extensive physical pain, tiredness, sleepless nights, anxiety, and despair. With upcoming clinical and safety trials, it might be safe to say that psychedelic compounds like SP-26 will join the two most popular treatments for fibromyalgia, non-steroidal anti-inflammatory drugs (NSAIDs) and gabapentinoids (Lyrica, Neurontin), to provide relief for patients. On the plus side, patients will be able to survive without enduring the unpleasant side effects of conventional drugs.
Meanwhile, the use of psychedelics to treat medical conditions, particularly mental health conditions, including anxiety, depression, and other mental health issues, has gained popularity in recent years. In years, LSD, psilocybin, and other psychedelics may also be helpful for pain relief in modest doses.
FIBRO AND WEED, READ ON...
