GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) is one of the heavyweights in the cannabinoid drug industry in the United Kingdom. For over two decades, the company has responded to the displayed competitive potential of responding to the significant unmet patient needs. Its focus has been to improve the lives of thousands of patients in the UK and around the world.
Through this motivation and dedication, the UK cannabinoid supplier sets its footprint into the US market with its pipeline product nabiximols. The strategy to this includes tapping onto the multiple opportunities. The submission of an Initial New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) will be the first opportunity and should take place in 2021.
Through several constructive meetings with the FDA, GW’s CEO, Justin Gover, says that they are ready for the commercial opportunity in the U.S once they attain the approval of Phase 3 clinical program. Emphasizing the program details, he confirmed the company’s confidence in the product, adding that its performance would be a significant driver for the GW’s value.
The Anticipation of Developing Multiple Indications for Nabiximols
As nabiximols enters the crucial Phase 3 development stage in the US, GW says its initial focus will be on spasticity. It is an earmarked treatment for MS spasticity, Post Traumatic Stress Disorder, and Spinal Cord Injury spasticity. Outside the US, it is known as Sativex, and it is available in many countries as a mouth spray.
In other news, EPIDYOLEX from GW has obtained a classification from the UK Home Office as a Schedule 5 drug. The medicine was previously a Schedule 2 drug and could only be sold and possessed lawfully and with stringent record-keeping.
However, it will no longer be a controlled drug and can be sold less paperwork to the advantage of both patients, pharmacists, and healthcare professionals. The oral solution is of cannabidiol is branded as Epidiolex in the US and as Epidyolex in the European Union.
The UK is not the first country to relax and medical cannabis restrictions. Germany, Poland, Denmark, and Portugal already send the trend as many continue to pursue legalization.