Robert A. Hauser, M.D., Professor of Neurology at the University of South Florida in Tampa, talks about an item that looks like a breath strip that may be able to treat those with Parkinson’s.
Interview conducted by Ivanhoe Broadcast News in July 2016.
Explain what off episode feels like to a Parkinson’s patient.
Dr. Hauser: Off episodes are when a patient’s Parkinson’s disease medication wears off and is no longer providing good benefit. Initially, when patients go on the main Parkinson medication (Sinemet, carbidopa/levodopa) they can take it three times a day and it provides good benefit from dose to dose. But after a few years they find the medication lasts a few hours and then wears off. When that happens they experience a return of symptoms such as slowness, stiffness, tremor and gait problems. When they’re slow and stiff and have difficulty walking, they are at risk for falls, they may feel very restricted, can have difficulty doing their job, and may feel anxious or even have difficult thinking.
How incapacitating are these off episodes?
Dr. Hauser: There’s a progression. Initially patients first notice a little bit of wearing off of the medication effect, but as time goes on, the duration of the medication effect becomes shorter and these off episodes last longer and become more severe. It varies from patient to patient but the longer the disease goes on and the longer the patient has been treated, the more severe the off episodes become. For many patients, off episodes become very severe such that they’re quite immobile and can’t walk.
What are the current treatments for the off episodes?
Dr. Hauser: The first thing that is usually done is to move the main medication (Sinemet, carbidopa/levodopa) doses closer together and to give more doses through the day. Most patients can usually take 4 daytime doses with an initial good response. But as time goes on and the duration of the medication effect further shortens, additional steps are required. However, patients often find it difficult to take more than 4 daytime doses plus a bedtime dose. We can add additional medications on top of the main medication, the so-called adjunctive medications that make carbidopa/levodopa last a bit longer. But they only help a little. And again, some time, we may find the patient now taking the main medication four or five times a day plus an adjunctive medication or two and they still find that the medication effect only lasts two and a half to three hours. Many of these patients currently go on to deep brain stimulation surgery.
As far as the experimental medicine that looks like the breath strip, how did that come to be?
Dr. Hauser: The medication that is currently in development is a strip that contains apomorphine. Apomorphine is a dopamine medication. It’s called a dopamine agonist because it acts like dopamine in the brain. Patients place the strip under their tongue and the apomorphine is absorbed from the mouth into the bloodstream and up to the brain. The rationale behind the medication is that it should be absorbed relatively quickly and provide quick benefit. The hope is that when patients start to enter an off episode they can put the strip under their tongue and it will relieve the off episode and provide good benefit for Parkinson’s symptoms. This is what is now being evaluated in clinical trials.
It provides benefit until the next medication dose takes effect?
Dr. Hauser: Early studies suggest that the apomorphine strip should provide benefit within fifteen to thirty minutes, and it may last sixty to ninety minutes, although these effects are still under investigation. The idea though, is to relieve or abort an off episode, and provide benefit until the next oral medication kicks in so as to provide a bridge from one oral dose to the next.
It’s something a patient can carry with them if they’re out and about, if they feel it coming on?
Dr. Hauser: Many patients can feel the off episode starting and it’s different for different people. Some patients start to feel a little tremor. Some feel the slowness or stiffness coming on. Others start to feel an internal sensation of anxiety or just a feeling of being off. If they recognize they are going in to an off episode, they can potentially abort it early before it becomes too severe.
At this point why do you think this breath strip is so innovative, do you think this is a breakthrough?
Dr. Hauser: There’s currently an apomorphine formulation that’s for injection to treat off episodes but it’s not very widely used. This may be because patients often don’t want to take injections; they can be painful and cumbersome. It’s hoped that we’ll have easier to use, more convenient treatments for off episodes in the future and perhaps the apomorphine strip will fill that niche.
How far along is the clinical trial, is this something that can be available to the public?
Dr. Hauser: The Phase II open label trial has been completed and the results are publicly available. A Phase III clinical trial, comparing the apomorphine strip to placebo, is ongoing now. If that study confirms the safety and efficacy of the medication, it could be available in just a few years.
As far as Parkinson’s disease goes do you feel like it’s come a long way in treating it, do you feel like there’s a handle on it like to deal with it different with every patient?
Dr. Hauser: There are several big problems in the treatment of Parkinson’s disease that we need to overcome. One is this problem that the main medication only last a few hours and wears off in patients who’ve had the disease for five to ten years or more. We’re making good inroads in this area with longer-acting medications and medications to bridge between doses such as the apomorphine sublingual strip with several new medications in development. But there are also longer term problems, problems that typically become problematic ten, twelve, fifteen years after diagnosis that we need to conquer. These include balance difficulty and thinking and memory problems. For those, I think we need to learn how to slow down and ultimately stop disease progression. We need to be able to diagnose the disease as early as possible and then administer a medication that will slow or stop disease progression. Fortunately, there’s been a revolution in our understanding of the basis of the Parkinson’s disease as it appears to involve clumping of a protein called alpha-synuclein. Laboratories around the country are investigating how we stop this process. We’ll see a lot of these medications tested in clinical trials in the next few years.
Can people still be part of the trial?
Dr. Hauser: The Phase III trial for apomorphine sublingual strip is underway now and is enrolling patients across the country. Patients can go to clinical trials.gov to find a site nearby.
Are there certain requirements?
Dr. Hauser: It’s for patients who are currently taking the main Parkinson medication (Sinemet, carbidopa/levodopa) and experiencing motor fluctuations such that the medication effect is wearing off between doses.
Levodopa is the treatment that is most common?
Dr. Hauser: Yes, Sinemet or carbidopa/levodopa is considered the most effective medication for Parkinson’s disease right now.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
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