What’s Next For Epidiolex Maker GW Pharmaceuticals

For almost four decades, marijuana has been classified as a Schedule I drug, more tightly regulated than opium or cocaine.

Obviously, it’s a big moment for medical marijuana. CBD, which parents of epileptic children in certain areas have risked criminal penalties to obtain, may soon be available nationwide.

“We believe that Epidiolex will be scheduled likely in the Schedule IV or Schedule V categories, which can be similar to other antiseizure medicines. ”

“It’s an exciting and historic approval. ”

The FDA announcement has fueled all kinds of speculation, from questions of rescheduling to speculation within the purchase price of Epidiolex. It also raises the question of what other drugs GW Pharma has in the pipeline.

Leafly recently spoke with Schultz about the significance of the FDA decision, when Epidiolex might become available to patients, and what’s coming next from GW. Below is an edited transcript of the conversation.

Leafly: This week brought big news that the FDA had granted approval to Epidiolex, a plant-derived CBD infusion that’s revealed rather remarkable success treating childhood epilepsy. Can you start by explaining a bit about Epidiolex’s effectiveness?

Schultz: GW Pharmaceuticals and our US subsidiary, Greenwich Biosciences, conducted a full clinical development program for Epidiolex, which can be purified CBD. That program yielded three placebo-controlled, robust clinical studies, all three of which have been printed in top-tier journals–two at the New England Journal of Medicine and one in The Lancet.

The information is extensive, and covers both Dravet syndrome and Lennox-Gastaut syndrome, forms of epilepsy in patients that are treatment resistant, that’s the huge majority of those inhabitants. Those trials yielded in-depth information about both the safety and the efficacy of our product.

We found that there were statistically significant reductions in the primary endpoints–seizure reductions for different types of seizure conditions. There were side effects associated with the medicine also.

These patients are generally on multiple medicines.

Now that the FDA has approved Epidiolex, what happens next? Do we have any sense yet of when the medication might actually become available to patients?

This first step was acceptance, and we have that behind us. The next step is for the DEA to reschedule the item, which we expect to happen within 90 days of yesterday’s acceptance. The rescheduling are the result of an investigation that the FDA does, and then hands off to the DEA. The DEA then utilizes abuse-liability information that we included in our new medication information, in addition to whatever data they decide to include in their investigation. And we expect that process to conclude within 90 days.

The drug must be rescheduled–the definition of [Epidiolex] because it was approved demands that it be transferred out of Schedule I. The abuse analysis study was reflected on from the April 19 FDA advisory committee meeting, which was a public meeting. That analysis suggests a very low abuse potential for this purified CBD, so we would expect the rescheduling would wind up on the less-restrictive end of the scheduling spectrum.

You’re saying you’re expecting a bigger shift than simply moving CBD to Schedule II?

The scheduling is Schedule I through Schedule V, and I think we believe that Epidiolex will be scheduled likely in the Schedule IV or Schedule V categories, which can be similar to other antiseizure medications, benzodiazepines, and products of that nature.

I recognize the FDA trials needed to do with epilepsy, but obviously anecdotal evidence suggests CBD has medical possibility to do far more than that. Could the acceptance of Epidiolex mean wider availability of CBD for things like chronic pain, anxiety, and other problems?

It’s a fantastic question. The FDA requires, however, that firms evaluate their medications in particular patient populations. They do this for good reason, because different patient populations and different therapeutic targets may react differently to the exact same medicine. For an approved medicine such as Epidiolex to be distinguished by the scientific evidence, it needs to be distinguished through the clinical information that we’ve developed.

While the prescribing of a medicine is between the patients and their physicians, Greenwich Biosciences won’t promote the drug outside of the Dravet and Lennox-Gastaut inhabitants. That would be inappropriate, and again, the decision to prescribe any medicine is between the doctor and their patients.

One of the things that’s most notable about this FDA approval is it’s the first time regulators have OK’d a medicine actually derived from the cannabis plant rather than synthesized in a lab. Is that significant as far as GW Pharma is concerned, and if so, why does that matter?

For us, it’s important because what it does is it gives us a sense of validation that the path we’re on and the way we produce our medications –that is through the use of plant-derived cannabinoids–is a path that works. It’s a path that the FDA clearly looks at favorably if done correctly, and it’s a path that can yield an FDA approval.

That gives usand it may give others that plan to work in this area too –confidence to proceed with a range of different medications and to continue to expand the work we’re doing with Epidiolex from the epilepsy area, also.

As you probably know, the acceptance of Epidiolex has caused a bit of a scare among some in the bud community, especially those who stress the value of “entire plant” extracts containing other potentially beneficial cannabinoids. Some worry this could really be a drawback for folks that are more whole-plant focused. Do you have any ideas on that?

Not really, no. Our idea is that other CBD options are really not for us to comment on.

“We expect to bring Sativex to the United States, put it into clinical development, and attempt to get it in front of the FDA as quickly as possible. ”

We developed our medicine in the way that we did since we believe that patients and physicians desire a CBD medicine to treat these difficult seizure conditions, because they need a medicine with the hallmarks of a modern medicine. It doesn’t vary at all–every time they take it–that is a problem with many of the other products. It offers the scientific evidence that we discussed earlier and the education of posts like the New England Journal of Medicine article and The Lancet article, to enable physicians to understand the medicine in more detail and how to utilize it, the way to bring it in their clinics. And it also offers the potential for reimbursement through the patient’s insurance program.

We believe there is a significant demand for something that has those traits, which ’s why we take this approach.

You said that Epidiolex might be covered under insurance, but already the New York Times has reported that Epidiolex could cost somewhere between $2,500 and $5,000 a month. Is that true, and if so, what options are there to make this more affordable to people who may benefit from it?

We have not set a price for the medicine yet, and we won’t do this until we have the rescheduling by the DEA. Therefore it’s difficult for me to comment on other price speculation, but I believe the New York Times quotes are likely higher than we’re modeling at the moment.

That said, we want to make certain that our medicine, after it’s available, can be utilized by patients who need it and patients who want to have the pharmaceutical CBD merchandise. There are a variety of strategies for us to enable this, but I’d prefer not to go into a great deal of detail because some of them are still in development. Suffice it to say our company’s aim is to make certain that patients with Dravets syndrome and Lennox-Gastaut syndrome are able to access the medicine if they need it.

Occasionally, when a state legalizes cannabis, customers that are utilized to pre-legalization prices often wind up staying in the illicit market in order to have access to a cheaper product–at least until prices fall. Is GW Pharmaceuticals worried about competing with high-CBD cannabis oils already available in medical marijuana dispensaries and adult-use markets?

In our discussions with patients and physicians, we see significant demand for the FDA-approved pharmaceutical medicine. It’s one reason we developed the medicine, and we still stand very confident it is a product that will be selected by physicians and patients for the treatment of the seizures at the Dravets and Lennox-Gastaut inhabitants.

That said, the choice is between the patients and the physicians. Whatever they choose as the best path for their particular case is a choice for them and not us.

What other cannabis-derived drugs does GW Pharma have in development?

We intend to keep on evaluating Epidiolex in treatment-resistant epilepsies. In fact we have a trial ongoing right now for a condition called Tuberous-Sclerosis Sophisticated, or TSC, which features seizures as a primary comorbidity of the condition. We expect data for this in 2019. We’ll likely continue to look to expand the Epidiolex label by initiating additional clinical trials for different forms of treatment-resistant epilepsy also.

It’s a very painful condition. We expect to bring it to the USA, put it into clinical development, and attempt to get it in front of the FDA as quickly as possible.

Beyond Sativex, we are considering expanding on the clinical evaluation of many products that have gone through early proof-of-concept studies. Those products include therapeutic regions of schizophrenia; of neuroblastoma, which is a very aggressive type of brain cancerand also we expect to initiate clinical studies later this year in autism spectrum disorders and especially one disease, called Rett syndrome, which is a very difficult autism spectrum disorder that affects mostly young girls.

Basically, that is the way we develop our science: We look at the cannabinoids, either individually or in combination–Sativex is a blend of CBD and THC–and we evaluate those cannabinoids against different therapeutic targets in preclinical and ultimately in clinical evaluation with the objective of bringing them in front of regulators and having them accepted for use.

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