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Dr. Krieger: 
Hello, everyone. Thank you for joining us. I'm Dr. Ana Krieger. I'm a Professor of Clinical Medicine at Weill Cornell in New York City. And it is my pleasure to be here today with Dr. Kevin Trice to speak about Safety of Oxybates in Narcolepsy. Dr. Trice, thank you for joining us.

Dr. Trice: 
Thank you so much for having me. I'm excited to be here.

Dr. Krieger: 
It's a pleasure to have you. So, let's discuss today about oxybates and its safety in narcolepsy patients. So, how would you select patients to identify the best people that will be more - have higher chance of benefiting from oxybates.

Dr. Trice: 
You know, narcolepsy patients can be complex. This is a chronic neurological condition, and there's multiple medications. But I think having about 20 years of real-world experience available with oxybates, it makes it a little bit easier to prescribe. So, we look at first and foremost, the history, the clinical indication, symptoms, and particularly if patients are having symptoms that are uncontrolled. Are they having excessive daytime sleepiness? Are they having cataplexy? Are they having disrupted nighttime sleep? Are they having hallucinations? And we're looking to see if the current treatment modalities are sufficient, or does there need to be an escalation in therapy? And those patients who may not be optimally controlled, we educate them and kind of come to a consensus between the provider and the patient as to what might be the next step or two steps in terms of adding treatments. And I think oxybates play a significant role in that place.

Dr. Krieger: 
That's excellent. That's so important for us to keep in mind how to select patients appropriately for the therapies that are available. So, are there patients that maybe would be better candidates for the lower sodium option of oxybates?

Dr. Trice: 
Absolutely. We know that the cardiovascular risk in narcolepsy patients can be elevated and also patients can be on oxybates, and particularly one form of it may increase their cardiovascular risk just by itself. So, in patients who have known cardiovascular disease, like underlying hypertension or heart failure, of course, there may be better options. I think the reality is we really just have to monitor the patient, educate them, consider lifestyle changes, dietary changes, to really manage all of their cardiovascular risk factors, and not just their symptoms of narcolepsy.

But I think adding oxybates to most patients with narcolepsy has a beneficial effect in terms of maybe treating more than one symptom with just one medication. We've known over the years, we've always been a little nervous in certain subsegments of the population, maybe those who are on antidepressants, or have alcohol use, who have a history of drug abuse, or other concomitant medications that may potentiate the effect of oxybate and kind of increase some of the risks. But after years and years of watching this, we now have better ways of kind of communicating that with patients and finding and selecting the patients. Of course, we can start low, go slowly, evaluating for side effects and also effectiveness. And as you mentioned, maybe even a different formulation of oxybate, which wasn't available for many years, to help with patients who may have issues with waking up in the middle of the night, or high sodium or other things like that.

Dr. Krieger: 
Thank you so much, Dr. Trice, for what you mentioned, because that kind of raises two other important questions. One is, are there patients that would benefit from once-nightly dose instead of a twice-a-night regimen?

Dr. Trice: 
Absolutely. You know, one of the pillars of narcolepsy can be the disrupted nighttime sleep. And I think in the past, we may not have done a good job of asking patients about dosing and their environment and how often they're taking twice-nightly, or really even evaluating their sodium affecting their cardiovascular risk. So, I think other formulations of the traditional oxybate have roles in patients as we realize a lot of patients have frequently interrupted sleep at night, they might benefit by not taking it twice. Other patients may have reasons why they want to take it twice a night. And some patients may have increased cardiovascular risk, either because of diet, because of exercise, because of genetics, sodium load, and they may benefit from a lower sodium formulation of it. So, I think that's the individualization that we really have to have with our patients when we're educating them about its benefits, but also its side effects.

Dr. Krieger: 
Excellent. And the other part of that question was, are there patients that you would avoid using oxybates?

Dr. Trice: 
You know, it's a tough question. I think there's always the risk. Of course, the act of avoiding this drug is something that always gives a little bit of pause. I think with proper education, most patients are good candidates. But clearly, if you have somebody who's unable to really kind of stick with the program, who may be unable to avoid other medications that could really potentiate the risk, or in those patients who have tried and have not really got great benefit from it, which is usually a rarity, but in those patients, clearly you may have to try to find another option.

Dr. Krieger: 
That’s phenomenal. This is so comprehensive and so important for all of us to implement in our practice and pay attention to individualized care given all the amazing options we have.

So, thank you so much, Dr. Trice, for your contribution.

Dr. Trice:
Thank you. Appreciate it.

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