Summary: Fibromyalgia is a common chronic disorder causing body aches, fatigue, tenderness in various body parts, depression, sleep disorders, and more. The condition is caused by certain changes in the brain that remain poorly understood by science. Doctors treat fibromyalgia using painkillers, antidepressants, and other medications, but the treatment is far from satisfactory. However, new studies suggest that psychedelics like psilocybin or LSD may help in chronic pain treatment, as they can help reset the brain, providing long-term relief in the condition.
Fibromyalgia is among the most complex disorders to diagnose and treat. Fibromyalgia causes widespread body aches. There are multiple areas of high pain sensitivity. Not only that, but it also causes fatigue, sleep disorders, depression, and more.
However, the condition is still poorly understood by science. That is why it remains a diagnosis of exclusion. Before confirming the diagnosis, doctors would generally exclude other well-known chronic health disorders causing similar symptoms like body aches and fatigue. Its diagnosis is mainly clinical, and there are no reliable biomarkers to confirm it. Nevertheless, it is among the common causes of chronic pain. What is worrisome is that its incidence is increasing.
There is no single drug therapy that would work for all. Thus, doctors would prescribe non-inflammatory drugs and anti-seizure medications, like gabapentin, and antidepressants, to treat the condition. However, the benefit from most of these drugs is far from satisfactory, and the risk of side effects from such treatments is high. Thus, there is a need to find safe medications to treat the condition.
In recent years, doctors have understood that fibromyalgia is caused by some brain changes causing hyperalgesia and fatigue. Thus, body tenderness in the condition is rather due to changes in the brain and not due to some local inflammation. Hence, it is vital to explore drug therapies that may help alter the brain’s working. Psychedelics are known to help reset the brain and provide prolonged benefits for many brain disorders. However, psychedelic therapy still remains largely experimental in various health disorders.
Now, one of the pharma startups has decided to explore the role of psychedelics in managing fibromyalgia. A California-based company called Tryp Therapeutics has partnered with the Chronic Pain & Fatigue Research Center at the University of Michigan Medical School for a phase 2 study regarding the use of psilocybin to treat fibromyalgia.
There are many reasons to consider psilocybin. It is the psychoactive compound found in “magic mushrooms” and is known to be relatively safe. Thus, researchers do not need to spend years generating pre-clinical data, and they also do not need to start with a phase 1 study, which mainly focuses on the safety of the compound and its humans. It is because there is already sufficient information about psilocybin, and its safety in humans is established to a degree. It has the potential of becoming the best treatment for fibromyalgia.
Of course, phase 2 studies are also about safety, but they are more extensive than phase 1 studies. Moreover, they also focus on efficacy at a safe time. Thus, the possibility of starting from the phase 2 study means much savings in both financial terms and timelines.
The company will test synthetic psilocybin. Early studies suggest that psilocybin can alter neuroplasticity, alter many neural networks, and cause long-term changes in brain function. Hence, it is likely that it may help reduce hyperalgesia of central origin often found in those with fibromyalgia.
Everyone is very excited about the study, as its success may change how fibromyalgia is managed and may even affect how chronic pain treatment and depression management is carried out. But, of course, these are still early days, as the company is still only getting ready to file for phase 2 trials. Such a trial needs to enroll a few hundred people. However, for the US FDA to approve the drug for medical use, there would be a need for a phase 3 trial, which is much more extensive.
So, sure, there is still a way to go. Nevertheless, the news is exciting, as pharma companies have started looking beyond traditional painkillers or antidepressants to manage such conditions. Moreover, there is limited evidence that antidepressants work for fibromyalgia.
Even more interesting is that other pharma companies have also started exploring the role of psychedelics in managing fibromyalgia. Thus, another company, Mind Medicine, has announced that they are beginning their investigation regarding the use of LSD to treat chronic pain syndrome and get cluster headache relief.
To date, LSD and psilocybin are classified as Schedule 1 controlled substances; hence, they are not approved for any medical use. However, these studies may change all that.
By Gurpreet Singh Padda, MD, MBA, MHP