Vertanical Seeks EU Approval for Cannabis Extract Drug VER-01 to Treat Chronic Back Pain
Vertanical, a German pharmaceutical company, has submitted an application for European regulatory approval of its cannabis extract drug, VER-01. The drug is designed to treat chronic lower back pain, with potential approvals also sought for arthrosis and diabetic peripheral neuropathy. The application is based on a clinical study involving 800 patients, which demonstrated VER-01's efficacy in relieving chronic back pain without the typical risks and side effects associated with opioids.
The study, conducted by Vertanical, found that patients experienced a nearly 2-point reduction in pain on an 11-point scale after 12 weeks of taking VER-01. Notably, participants also reported improvements in sleep and physical function. The drug's formula contains THC, the active ingredient in marijuana that causes a high, but at very low levels. While side effects such as dizziness, headache, fatigue, and nausea were reported, leading to over 17% of patients discontinuing the drug early, Vertanical believes VER-01 could offer a safer alternative to opioids for treating chronic back pain. Vertanical is now seeking approval for the drug in Europe and is working with U.S. regulators for FDA approval.
Vertanical's cannabis extract drug, VER-01, has shown promising results in treating chronic lower back pain. With approvals sought in Europe and the U.S., the drug could provide a safer option for patients, reducing pain, improving sleep and physical function, and potentially replacing opioids in the future.
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