US cannabis producer Flora Growth, which is conducting the study in conjunction with the University of Manchester, hopes to gain approval from UK regulators in the coming months.
Cell and animal-based studies are already underway, led by the Flora Growth research team in the US. The lead scientific advisor, Dr Annabelle Manalo-Morgan, told Cannabis Health she plans for human trials to be up and running by this summer.
Flora Growth has teamed up with an internationally recognised clinical research group based at the University of Manchester to explore the use of cannabinoids in patients who have fibromyalgia and chronic pain.
It aims to fast-track regulatory timelines by running different phase trials in parallel. If successful, the findings could lead to Flora’s cannabis-based products being prescribed through the NHS.
“We have a series of formulas that we’re going to be testing, which are hemp-derived and more abundant in CBD,” says Dr Annabelle Manalo-Morgan, whose background is in cellular biology and neuroscience and formerly worked for the US Food and Drugs Administration.
Dr Annabelle Manalo-Morgan, scientific lead at Flora Growth
“We chose the UK because we wanted to turn some heads and show that somebody as conservative as the NHS would give us approval.
“We’re going to have an NHS-approved product – or products, hopefully – but we’re also creating data that will allow others to have a threshold of what they can bring to the market.
“Once they trust us and have looked at our studies, then we can work to open the door to studying other cannabinoids.”
Dr Manalo-Morgan says she has had “preliminary conversations” with regulators and hopes to collect data from up to 1,000 patients.
“The fact that we can have preliminary conversations and get a feel for exactly what they want shows that they trust who is going to be doing this first NHS-approved study because of our academic and scientific background,” she adds.
“It also shows us that they are willing to have cannabis as a part of the conversation.”
“Rewarding results”
As many as 1.5 million to two million people live with fibromyalgia in the UK, and up to four million Americans are thought to have the condition.
As well as chronic pain and stiffness, symptoms include fatigue, brain fog, trouble sleeping, digestive issues, anxiety and depression.
As well as examining how cannabinoids can help patients manage their pain, Flora Growth will also analyse the effect on anxiety, depression and overall inflammation, as well as consider the perception of pain and the impact this has.
“By carrying out a study on fibromyalgia, we can collect data on more than just pain,” says Dr Manalo-Morgan.
“We can study anxiety, depression, pain and inflammation, so not only are we going to be able to define the cannabinoids’ role in fibromyalgia, we’re going to be able to define fibromyalgia better.
“I’m excited about the ability to look at different data points simultaneously because I think these results will be rewarding.”
Dr Manalo-Morgan has just completed cell-based toxicity studies in the US, and animal studies are showing “positive” results; she says: “We’ve pushed the doses quite substantially, beyond the data that’s already out there, and generally have not seen any toxicity, which we expect.”
Subject to this data gaining approval from the NHS Ethics Committee, the trial could recruit patients in the UK in the next few months.
Dr Manalo-Morgan adds: “You have thousands of advocates, millions worldwide, that are pushing for this. Let’s provide the science that will no longer allow people to deny cannabis and for people to have access to it when they need it.”
