Israel’s Intec Pharma has initiated a Phase 1 clinical trial evaluating AP-CBD/THC to treat several disorders including fibromyalgia and lower back pain.
The Jerusalem-based company developed AP-CBD/THC using its Accordion Pill platform containing the two cannabinoids most present in Cannabis sativa – cannabidiol (CBD) and tetrahydrocannabinol (THC). The therapy aims to extend the absorption phase of CBD and THC, resulting in an improved therapeutic effect.
AP-CBD/THC can potentially address certain drawbacks of current cannabinoids, including short effect duration, delayed onset, variable exposure and variable dosage, among other adverse events that correlate with peak levels.
Cannabis sativa is used to treat chronic pain and other indications. Previous studies have shown that plant extracts containing certain amounts of CBD and THC could potentially treat chronic, neuropathic and inflammatory pain conditions that do not respond positively to currently available treatments.
The Phase 1 study is a crossover trial designed to compare the pharmacokinetics, safety and tolerability of two formulations of AP-CBD/THC with Buccal Sativex (an oral spray containing CBD and THC) in 21 randomized healthy volunteers from one site only. Participants will receive a single-dose of the drug. Topline results are expected in the third quarter of this year.
“The progression of AP-CBD/THC into the clinic is a significant achievement for Intec and marks a major step forward in developing a potential new therapy for pain management. It is also our first demonstration of the Accordion Pill platform for cannabinoid therapies.” Zeev Weiss, Intec Pharma’s CEO, said in a press release. “Moving forward, we plan to evaluate the Accordion Pill platform in several other indications where a safe, effective, prolonged and consistent cannabinoid therapy may be able to provide therapeutic benefit where other treatments have failed.”
Cannabis-derived products are gaining medical attention and will likely represents about 10 percent of the specialty pharmaceutical market over the next five years, according to the company.
Fibromyalgia is a chronic musculoskeletal pain disorder that affects 2 to 5 percent of the U.S. population, primarily women. Common symptoms include chronic widespread pain, nonrestorative sleep, fatigue and morning stiffness.