CBDs Enabling Improvements In Treatment Resistant Epilepsy

CBDs Enabling Improvements In Treatment Resistant Epilepsy

Evidence has been just been released revealing that CBD oils can significantly improve seizure frequency, symptoms and other measures of efficacy in patients suffering with treatment resistant epilepsy, as published in the journal Epilepsy and Behavior.

Results of this study from researchers at the University of Alabama indicate use of CBD oil reduced adverse events and seizure severity along with decreases in overall seizure frequency. 132 patients were included in this study: 60 adults and 72 children with intractable epilepsy who did not respond to traditional therapies. Subject data was analyzed at baseline and again from visits at 12, 24, and 48 weeks. Frequency of seizures decreased from mean of 144 seizures every 2 weeks at baseline to 52 seizures over 2 weeks, decreases remained stable the course of the 48 week study period of nearly a two thirds reduction across the entire population with some experiencing even greater reductions.

Patients were scored on adverse events profile or AEP scores which decreased from 40.8 at baseline of CBD therapy to 33.2 at the 12 week visit for all subjects; and Chalfont Seizure Severity Scale was used to assess overall severity of seizures, with decreases from 80.7 baseline to 39.2 at 12 weeks: decreases in scores from both measures remained stable at the 48 week mark.

Improvements of 10+ points on the CSS Scale are clinically significant; improvements were observed of 30-40 points at the 12 week mark for each group from baseline, and as much as 50-60% improvements demonstrating results are statistically and clinically significant.

Parallel decreases in seizure severity and frequency were noted indicating for many patients use of CBD oil led to fewer seizures and less intense seizures in adult and children patients with intractable epilepsy who did not respond to traditional therapies.

Oil used in this study was pharmaceutical grade Epidiolex CBD oil produced by Greenwich Biosciences. Epidiolex has been shown in observational and randomized controlled studies to confirm tolerability and safety; data analysis showed significant decrease in overall side effects reported by patients.

AEP scores remained stable throughout the study despite increases in CBD dosing and decreases in other anti-seizure medication. Only 2 subjects were noted in the pediatric group and 2 in the adult group withdrew from the study due to adverse events alone.

Results of the open label safety study indicate significant improvements in seizure severity, frequency, and adverse effects at 12 weeks, with maintained response over duration of therapy for 48 weeks. Enrollment of patients with specific diagnosis of all ages with various treatment resistant epilepsy indicates that CBD oil may be effective across the spectrum of epileptic conditions.

Epidiolex was approved by the US FDA on June 25, 2018 for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome making it the first FDA approval of a purified cannabis derived drug, paving way for future additional efficacious well tolerated treatment options.

Materials provided by:
Note: Content may be edited for style and length.

Source: WorldHealth.net

GW Pharma Reveals Epidiolex Pricing

GW Pharma Reveals Epidiolex Pricing

GW Pharmaceutical released financials for its fiscal 2018 Q3 after the close today and hosted a conference call for investors and analysts. Readers can access a full transcript provided courtesy of Seeking Alpha. As the company nears the launch of its cannabis-derived treatment for seizures in patients with rare forms of epilepsy, the investor community is focused almost exclusively on Epidiolex and its commercialization.

One of the big questions for the company in recent quarters has been its expected pricing, and the company revealed during the conference call for the first time that Epidiolex will cost $32,500 per year on average, depending upon the weight of the patient and the dosing. The goal of the company, according to Julian Gangolli, who, as President, North America, is leading the company’s commercialization efforts, was to keep the price “in line with other branded antiepileptic drugs used to treat these intractable conditions.” The company later indicated that the price, which appears to be on the lower end of range of prices that analysts have expected, was a function of feedback from insurance companies. While GW Pharma reported that its talks with payers have been productive, it didn’t announce any formal agreements. The company also expects that Medicaid will represent an important payer, though there is still no reimbursement agreement announced.

GW Pharma also revealed that its current base of patients receiving Epidiolex through the expanded access program will continue to receive the product free of charge until it begins to migrate these patients to commercial product by mid-2019, choosing instead to focus its efforts on getting new patients. During the Q&A, no analysts questioned the financial impact of this move, which is likely to result in higher revenue over time but to depress it in the near-term. Going into the call, the analyst consensus for FY19, which is predominantly a function of Epidiolex sales, was $135 million, according to Sentieo.
Management also pointed to its efforts to educate patients, caregivers and the physician community, including the launch of websites CannabinoidClinical.com and TakeOnEpilepsy.com, but it cautioned that “it may take time for physicians to learn how to use the new medicine and adopt it in their clinics and for payers to provide reimbursement coverage.”