Medical Cannabis Drug Watch: GW Pharmaceuticals is again hoping to get another approval from FDA

GW Pharmaceuticals (NASDAQ: GWPH, GW, the Company or the Group), a British medical cannabis company, is known to be dedicated to the development of plant-based cannabinoid drugs. For the past 20 years, the company has been studying about the medical benefits of cannabis. Since 1998, GW Pharmaceuticals has been focusing on the treatment of different neurological disorders like schizophrenia, epilepsy, multiple sclerosis, autism, and many more.

On seeking another FDA approval

Earlier this year, GW Pharma is again attempting to gain another FDA approval for its prescription drug Epidiolex. Currently, Epidiolex is one of the company’s leading products against the rare and severe drug-resistant epilepsy syndromes. On this note, the company has announced that FDA has given the drug a priority review during its new drug application. This New Drug Application (NDA) is for the use of Epidiolex as a drug treatment for the symptoms (i.e. seizures) linked with Dravet syndrome and Lennox-Gastaut syndrome. The company is expecting to have the review completed by June this year.

One of the most important reasons why investors need to keep track on GW Pharma’s Epidiolex is exclusivity. When approved by the FDA, Epidiolex will be given a minimum exclusivity of five years. In other words, no other drugs of the same kind and properties will be allowed to be on the market until the expiration of the exclusivity. To make this situation more favorable to GW, Epidiolex is the only available anti-epilepsy drug that is prescribed to both children and adults. Because of this, the drug could be given an additional six months of exclusivity.

What’s in store for GW Pharma after the approval?

Once approved, Epidiolex is also assumed to give a boost to GW Pharma’s stocks. Many analysts believe that treatments from Epidiolex, at cost of about $50,000 annually, could result in a revenue of more than a billion dollars per year. These predictions are, of course, still depending on how FDA will deal with the classification of cannabidiol as a prescription drug, and how the DEA will schedule Epidiolex. Aside from these, it is also dependent on the multi-million CBD oil businesses that sell cannabidiols in different product forms.

With almost 500,000 children suffering from epilepsy in the U.S. alone, the company is estimated to gain nine figures in terms of its annual sales. Aside from Epidiolex, GW Pharma is also hoping to get FDA approval for its drug Sativex, a novel treatment drug for the management of the symptoms associated with multiple sclerosis. To date, the drug is available in more than 30 countries worldwide. They include Canada, the United Kingdom, Germany, and Switzerland. Despite its almost worldwide availability, the drug is not yet available in the U.S.

For a long time now, there have been quite a number of scientific studies, as well as anecdotal proofs, showing the efficacy of cannabidiols in minimizing the incidence of seizures in infants. With this, the struggle between affordable medical cannabis-based drugs and their expensive counterparts will occur in the battle for medical cannabis legalization in many states and countries worldwide.


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