First Pharmaceutical Formulations of Cannabidiol in Development for Multiple Sclerosis

MMJ BioScience is in the developmental stages of the first pharmaceutical formulations of a cannabidiol (CBD) derived from certain cannabis plant extracts. The company is also beginning phase 2 studies to examine the medication in primary progressive multiple sclerosis (PPMS).

Pharmaceutical CBD is a consistent, standardized formulation of CBD that meets chemical purity and quality measures, according to a press release.

The product is an oral pill consisting of a pharmaceutical formulation of purified THC and CBD. If approved, it will be the first in a new class of MS drugs, as well as the first FDA-approved prescription medication derived from marijuana.

“Multiple sclerosis is a disease that interferes with your brain’s ability to operate your body and it can be disabling,” said Denis Harris, MD, in a release. “Evidence suggest that the disease happens when your immune system attacks a substance called myelin. The myelin acts as a type of insulation on your nerve cells. This process can lead to damage in and around the nerves in your brain and spinal cord.

“A large percentage of these patients are resistant to currently available treatments and experience multiple symptoms including spasticity and pain. These conditions are difficult to manage and treatment options are currently limited, particularly in PPMS, for which there are currently only 1 FDA-approved treatment. The day-to-day impact of these devastating conditions are significant and, with high rates of mortality.”

The treatment will be studied in large, well-controlled clinical trials aimed at producing high-quality, substantial safety and efficacy data to submit as part of a New Drug Application to the FDA in early 2018.

Scientists at MMJ BioScience are creating a pipeline of clinical-stage cannabinoid candidates for orphan and non-orphan indications that primarily focus on MS neurological conditions, according to the release.