In the last trading session, the stock price of GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) closed marginally in green, indicating that the stock may attempt to recoup its last week losses. Earlier in October, the company reported that it has closed the rolling submission of a NDA to the USFDA for Epidiolex® as adjunctive treatment targeting seizures associated with LGS and Dravet syndrome. This task was closed along with the help of company’s subsidiary unit – Greenwich Biosciences.
GW Pharmaceuticals has been granted with Rare Pediatric Disease as well as Orphan Drug Designations from the USFDA for Epidiolex in the treatment of Dravet syndrome and LGS. Additionally, it has been given Fast Track Designation from the USFDA for Epidiolex for the cure of Dravet syndrome. Justin Gover, the Chief Executive Officer of GW Pharmaceuticals, expressed that the filing of the Epidiolex NDA is a significant achievement for people suffering with LGS and Dravet syndrome.
This indicates that there is a potentially new treatment option in horizon for these two difficult to treat and grave conditions. On behalf of company’s employees, patients and clinicians, who have been a part of the Epidiolex plan, they are pleased to file the NDA for this promising therapy for U.S. FDA review. The team look forward to offer every support to the FDA throughout the assessment course. This regulatory submission is an indication of GW’s commitment to developing unique cannabinoid-based treatments. The company is currently assessing additional clinical development plans in other orphan seizure disorders.
The NDA for Epidiolex goes with on the back of data from three Phase III safety and efficacy trials, each of which achieved their main endpoint. GW Pharmaceuticals intends to file a Marketing Authorization Application in Europe for Epidiolex in the imminent future. Epidiolex is a pharmaceutical formulation of purified CBD, which is in development for the cure of numerous rare childhood-onset epilepsy ailments.