Multiple sclerosis (MS) is a disease characterized by the destruction of insulating covers on nerve cells by the immune system. The most common form for the disease, relapsing-remitting MS, is characterized by clearly defined attacks of decreasing neurologic function (relapses) followed by partial or complete recovery periods (remissions). Research into novel therapy approaches continues to investigate safer, more effective alternatives to the currently approved MS therapies. The use of cannabinoid-based therapies in particular appear to show promise for controlling relapses in those with the disease.
MMJ PhytoTech, a drug development company working on cannabinoid-based therapies, plans to initiate clinical studies of new capsule formulations derived from cannabis for the treatment of MS later this year. Their phase 1, safety-oriented clinical studies have been approved by various ethics committees and public health organizations. The company has been actively investigating a new capsule that offers many advantages over smokeable cannabinoid formulations, as oral administration is much more controllable and user-friendly. Furthermore, the company is confident that their capsules can withstand room temperature storage for extended periods of time. In this way, the need for refrigeration is eliminated resulting in lower shipping and storage costs.
In the end, the company believes that these advantages will give rise to a low cost cannabinoid alternative with potentially high patient compliance. The safety of these Tetrahydrocannabinol and Cannabidiol capsules will be tested in a small group of volunteers to test for adverse effects. They are expected to have a low frequency of side effects and, if proven as such, the company plans to conduct Phase 2 clinical studies to investigate the efficacy and optimal dosing schedule for MS patients. After the studies are complete, the company will need to develop Phase 3 clinical trials to assess efficacy, effectiveness and safety of the drug in around 1,000 MS patients.
The availability of clinical trials is important for medicine as it helps in the development of the treatments of tomorrow. Patients participating in clinical trials help researchers get closer to discovering new and effective therapies and/or cures for the disease. Moreover, clinical trials also give patients access to experimental therapies that are otherwise unavailable and that might offer enhanced treatment benefits than currently approved therapies for MS.
The main goal of this research is to enhance the availability of highly effective cannabinoid extracts to the general public while lowering costs and developing and easier and more stable formulation, which could tremendously impact patient outcomes for those with Multiple Sclerosis.