First Cannabis-Based Medication for Chronic Pain to Launch in Europe
/By Pat Anson
The world’s first cannabis-based medication for chronic pain is expected to launch in Germany and Austria next month, after getting marketing authorization from regulators.
Exilby is a full spectrum extract derived from THC, CBD and terpenes found in cannabis sativa, a strain of cannabis known for its pain relieving properties. Exilby was approved for treatment of chronic lower back pain, although it’s likely to be prescribed for other chronic pain conditions.
“There is an extra or additional law in Germany, which says for all patients who do not have any adequate treatment left, our drug can be prescribed as well, whether they have low back pain or any other chronic pain condition,” said Dr. Clemens Fischer, founder of Vertanical, which makes Exilby. “We launch at the end of August in Germany and Austria, and then we go to Europe step by step.”
In the United States, Exilby recently received a Breakthrough Therapy designation from the FDA, which will speed up its development and review. But even with that designation, Exilby is not expected to get full FDA approval until 2028 or 2029, due to the slow regulatory process in the U.S.
Much of it hinges on the outcome of a Phase 3 placebo-controlled clinical trial that will evaluate Exilby as a treatment for chronic back pain caused by lumbosacral radiculopathy (sciatica).
Recruitment of 810 patients at various locations in the U.S. is expected to begin in the next few weeks, with the estimated completion date for the study in 2028. If the results are positive, then Vertancal will submit a new drug application to the FDA.
VERTANICAL IMAGE
The recent legalization of medical marijuana in the U.S. creates a faster potential pathway for Exilby. Medical cannabis products already approved at the state level is being reclassified by the DEA as Schedule 3 controlled substances, which allows for some medical use.
If Exilby were available in state-licensed marijuana dispensaries, it could enter the U.S. market much sooner. Fischer says he’s tempted, but unlikely to take that approach.
“We really want to go to the track of having a pharmaceutical and an FDA-approved drug, so this is actually the track we are following. But I think about it. Why not, right? It might be easier,” Fischer told PNN.
In addition to chronic low back pain, Vertanical hopes to eventually get FDA approval for Exilby as a treatment for osteoarthritis and peripheral neuropathy.
In two completed Phase 3 studies in Europe, Exilby was more effective than moderate doses of opioids (27-32 MME) in treating chronic low back pain. Patients taking Exilby also had better sleep quality and were less likely to be constipated. Each dose contains 2.5 mg of THC, but patients did not become “high” or intoxicated.
