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 that has 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 are 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 and without FDA approval. 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 a modest 2.5 mg of THC, but patients did not become “high” or intoxicated.

Cannabis Extract Gets Breakthrough Therapy Status From FDA

By Pat Anson

A German biopharmaceutical company says its cannabis extract has received a Breakthrough Therapy designation from the FDA, which will speed up its development and review as a potential treatment for chronic low back pain. 

If approved by the agency, the investigational extract – called VER-01 – would be the first cannabis-based medicine in the U.S. designated for the treatment of chronic pain. The full spectrum extract is derived from THC, CBD and terpenes found in cannabis sativa, a strain of cannabis known for its pain relieving properties.

"The FDA's Breakthrough Therapy Designation for VER-01 is a major recognition of its potential to address the significant unmet need in chronic pain," Dr. Clemens Fischer, Founder of Vertanical, said in a press release.

"Patients have waited far too long for meaningful progress. We believe VER-01 has the potential to change how chronic pain is treated and offer physicians a much-needed non-opioid solution."

If approved, VER-01 would be sold under the brand name Exilby and be taken orally in drops. The company is also studying VER-01 as a pain treatment for patients with osteoarthritis and peripheral neuropathy. 

The FDA’s Breakthrough Therapy designation was granted after two Phase 3 clinical trials found that VER-01 provided better pain relief to patients with chronic low back pain than low doses of opioids.

Patients taking VER-01 also reported improvements in nerve pain, sleep quality and physical function, and were less likely to be constipated than those on opioids.

Vertanical plans to launch a third Phase 3 placebo-controlled study in the U.S. to confirm the efficacy and safety of VER-01 in patients with chronic low back pain. The company anticipates the first data from that study in 2027 and, if they are positive, plans to submit a New Drug Application to the FDA in 2028.

VERTANICAL IMAGE

Vertanical hopes to get marketing authorization for VER-01 from European regulators in the next few weeks.

Research into the pain-relieving properties of cannabis has long been slowed in the U.S. by marijuana’s status as an illegal Schedule 1 controlled substance. The DEA is now allowing more cannabis to be used for research purposes and recently reclassified medical marijuana as a Schedule 3 drug, which allows for medical uses.

Cannabis Extract Provides ‘Superior Pain Relief’ Compared to Opioids

By Pat Anson

A German pharmaceutical company has released the results of two late-stage clinical trials, showing that a cannabis extract called VER-01 significantly reduces chronic lower back pain. The full spectrum extract, derived from cannabis sativa, provided better pain relief to patients in a head-to-head comparison with low doses of opioids.

Vertanical hopes to get regulatory approval of VER-01 in Europe and with UK regulators in 2026. If granted, VER-01 would be the first cannabis-based medicine approved for use in treating chronic pain. Another study of VER-01 is planned in the U.S. next year, which would be a step towards getting FDA approval.

Findings from the two Phase 3 studies were published separately in the journals Nature Medicine and Pain & Therapy.

“These findings provide powerful evidence that VER-01 could in the future transform how we care for patients with chronic lower back pain,” co-author Charles Argoff, MD, Professor of Neurology at Albany Medical College and past president of the American Academy of Pain Medicine, said in a press release.

“The results of the Phase 3 studies bring hope to millions living with chronic pain that VER-01, once approved, may provide effective pain relief without the risks and harms associated with existing therapies.”

Chronic lower back pain (CLBP) affects more than half a billion people worldwide and is the leading cause of disability. Current treatment options for CLBP are typically limited to physical therapy and non-steroidal anti-inflammatory drugs (NSAIDs), which often don’t work.

In the Phase 3 study, 820 patients with CLBP were given either a placebo or VER-01 over 12 weeks. Those who received the extract had an average pain reduction of 1.9 points on a zero-to-ten pain scale. After six months, pain intensity decreased by 2.9 points, which was sustained over 12 months. Participants also reported improvements in neuropathic pain, sleep quality and physical function.

The other Phase 3 study involved 384 patients with CLBP, who received either VER-01 or opioids for six months. Opioid doses started with a mean daily average of nearly 27 morphine milligram equivalents (MME) and were titrated up to an average of nearly 32 MME, a dosage range that would be considered low or moderate. Opioid options included tramadol, oxycodone, hydromorphone, morphine, and transdermal fentanyl or buprenorphine.

VER-01 was more effective in relieving pain than opioids, especially for patients with severe pain. The average pain reduction with VER-01 was 2.5 points on the pain scale, compared to 2.16 points with opioids. Patients taking VER-01 also had better sleep quality and were less likely to be constipated.

VER-01 was generally well tolerated in both studies, with no evidence of dependence or withdrawal. Side effects such as dizziness and nausea were mild and short-term. Although it contains THC, the main psychoactive substance in cannabis, patients did not become “high” or intoxicated. Each dose of VER-01 contained 2.5 mg of THC, as well as cannabinoids, terpenes and other bioactive compounds that were administered twice daily.

“This study provides robust evidence that VER-01 offers better tolerability, as well as superior pain relief and sleep quality compared to opioids in patients with CLBP. These findings highlight its potential as a promising new pharmacological option within a multimodal treatment approach that could fundamentally shift the paradigm in the treatment of chronic pain,” researchers concluded.

It approved, VER-01 would be sold under the brand name Exilby and be taken orally in drops. Vertanical is also studying VER-01 as a pain treatment for patients with osteoarthritis and peripheral neuropathy.

Research into the pain-relieving properties of cannabis has been slow in the U.S., in large part because of marijuana’s status as an illegal Schedule 1 controlled substance. Although the DEA allows more cannabis to be used for research purposes, the agency has dragged its feet about reclassifying marijuana as a Schedule 3 substance that could be used for medical purposes. Until marijuana is rescheduled, VER-01 is unlikely to get FDA approval. 

Experimental Cannabis Extract Has ‘Potential to Replace Opiates’

By Pat Anson

A German biotech company says it is seeking regulatory approval in Europe and the United States for an experimental cannabis extract that could be an alternative to opioid pain medication.

Vertanical recently completed two Phase 3 studies of its new drug – called VER-01 – on over 1,000 patients with chronic low back pain who didn’t get sufficient relief from non-opioid analgesics.

One study compared VER-01 to a placebo, while the second trial compared the drug’s safety and tolerability to patients treated with opioids. The company told The Times it was awaiting publication of the studies’ findings in The Lancet before making them public.

“VER-01 reduces pain without creating dependency or having an abuse potential,” said Clemens Fischer, MD, Vertanical’s CEO. “It has the full potential to replace opiates as it’s more effective. It’s a real alternative for chronic patients — the first one.

“Pain patients around the world are trapped in a vicious cycle of pain, insomnia, limited mobility, and depression. VER-01 has the potential to successfully break this cycle.”

VER-01 is a “full-spectrum” extract derived from cannabis sativa leaves and flowers. Although it contains THC, the main psychoactive substance in cannabis, Fischer says patients enrolled in the studies didn’t become high or intoxicated. About 25 percent did “feel a bit dizzy” for two weeks after they started taking it.

Participants also didn’t get “the munchies” or gain weight, a well-known side effect of cannabis.

“We were looking very carefully, because that’s what we hear from cannabis smokers — that the appetite increases as well their weight. But we haven’t seen any increase in weight,” Fischer told The Times.

Vertanical is seeking regulatory approval of VER-01 in Europe and with the UK’s Medicines and Healthcare Products Regulatory Agency. If granted, VER-01 would be the first cannabis-based medicine approved for chronic pain. It would be sold under the brand name Exilby and be taken orally in drops.

The timeline for approval in Europe may be as soon as this summer, but it’s likely to take longer in the U.S.

“We are seeking regulatory approval in the US and are in talks with the FDA. For approval in the US, a further phase 3 study with US patients in the indication of chronic low back pain will start in Q2 2025,” Merit Renner, Senior Manager of Business Development at Vertanical, told PNN in an email. “This, together with the phase 3 study successfully conducted in Europe, will form the basis for approval in the US.”

Vertanical also plans further studies of VER-01 on patients with osteoarthritis and peripheral neuropathy.

Research into the pain-relieving properties of cannabis has been slow in the U.S., in large part because of marijuana’s status as a Schedule 1 Controlled Substance, the same classification as LSD and heroin. The DEA recently allowed more marijuana to be used for research purposes, but has dragged its feet about reclassifying marijuana as a Schedule 3 substance that could be used for medical purposes. Until marijuana is rescheduled, VER-01 is unlikely to get FDA approval.

Some recent studies have shown that certain cannabinoids found in marijuana -- cannabidiol (CBD), cannabigerol (CBG), and cannabinol (CBN) – block pain signals in the peripheral nervous system, not the brain, and don’t have a psychoactive effect that could lead to abuse.

“These findings open new avenues for the development of cannabinoid-based therapies,” said Mohammad-Reza Ghovanloo, PhD, lead author of a study published in PNAS and a research scientist at Yale School of Medicine. “Our results show that CBG in particular has the strongest potential to provide effective pain relief without the risks associated with traditional treatments.”

The cannabinoids in the Yale study interact with a protein in cell membranes called Nav1.8, which blocks peripheral nerves from transmitting pain signals. Inhibiting Nav1.8 is the same method used by Journavx (suzetrigine), a non-opioid analgesic recently approved by the FDA for relieving moderate to severe acute pain in adults.