Insightec Announces Fda Approval Of Exablate Neuro For The Treatment Of Parkinson’s Disease
MIAMI, Nov. 3, 2021 /PRNewswire/ — Insightec®, a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy, announced today that the U.S. Food and Drug Administration has approved the Exablate® Neuro for treating advanced Parkinson’s Disease patients suffering from mobility, rigidity, or dyskinesia symptoms.
The Exablate Neuro uses focused ultrasound waves to precisely target and ablate the globus pallidus during a pallidotomy. The treatment is incisionless, does not require brain implants, and has less risk of infection than invasive surgery.
“Movement disorder neurologists now can offer their Parkinson’s patients a less invasive surgical option as part of their treatment plan,” Paul S. Fishman, MD, PhD, professor of neurology, pharmacology and neurobiology at the University of Maryland School of Medicine.
“This approval is significant in that it adds Focused Ultrasound as an incisionless surgical option to treat motor symptoms of Parkinson’s disease,” added Howard M. Eisenberg, MD, R.K. Thompson Professor, Department of Neurosurgery at the University of Maryland and Principal Investigator.
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“Exablate,” and “Exablate Neuro,” as well as the “INSIGHTEC” logo, whether standing alone or in connection with the word ” Insightec”, are protected trademarks of Insightec.
What Are The Symptoms Of Parkinsons Disease
Unfortunately, there are no treatments that slow or stop the progression of Parkinsons disease.
Levodopa is the most potent and prominent drug used to treat Parkinsons disease however, its effect tends to wear off over time and can lead to negative side effects including dyskinesia.
Drugs including COMT inhibitors, dopamine agonists, and non-dopaminergic treatmentssuch as anticholinergic treatments and amantadinecan be used as alternatives to levodopa, in addition to levodopa, or in combination with one another.
In people with advanced Parkinsons disease, when medications fail, deep brain stimulation can be considered to help alleviate symptoms.
Typically, medications are reserved for people whose symptoms have become severe enough to interfere with activities of daily living. Levodopa is usually the drug of choice in people aged 65 and older whose lifestyles are seriously compromised. People younger than 65 can be treated with a dopamine agonist.
Drugs are started at the lowest effective dose and treatment is typically delayed as long as possible. However, the research supporting the guiding tenet of start low and go slow with dosages of levodopa is mixed. According to author Peter Jenner:
However, Jenner goes on to note the following:
“The early use of L-dopa was also shown to be the most effective treatment for motor symptoms and not to affect the long-term risk of dyskinesia.”
Medication For Parkinsons Disease
Once the doctor diagnoses Parkinsons disease, the next decision is whether a patient should receive medication, which depends on the following:
The degree of functional impairment
The degree of cognitive impairment
Ability to tolerate antiparkinsonian medication
The advice of the attending doctor
No two patients react the same way to a given drug, therefore, it takes time and patience to find an appropriate medication and dosage to alleviate symptoms.
On Times And Off Times
“ON time” refers to periods when medications are adequately working and the symptoms of Parkinsons disease are controlled.
“OFF time” refers to periods when the medications wear off and Parkinsons symptoms, such as tremor, rigidity, and difficulty walking reappear.
The addition of safinamide to drug regimens of people with advanced Parkinsons disease taking levodopa increases the amount of ON time and decreases OFF time.
Safinamide Negative Side Effects
Because of negative side effects, 3.7 percent of participants taking safinamide dropped out of clinical trials as compared with 2.4 percent of those taking a placebo.
Common adverse effects observed during these clinical trials included the following:
- jerky or fragmented motions
Of these symptoms, dyskinesia was about twice as common in people taking safinamide as compared with those not taking it .
Less common but more serious adverse effects include the following:
- worsening high blood pressure
- visual hallucinations and psychotic behavior
- falling asleep during the day
- serotonin syndrome
- problems with impulse control or compulsive behavior
- fever and confusion
Here are some drugs that you shouldnt take if youre also taking safinamide:
- certain antidepressants
- St. Johns Wort
Although people with kidney impairment can take safinamide, those with severe liver problems should not take the drug.
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Fda Approves New Indication For Adamas Gocovri In Parkinsons Disease
Gocovri approved to treat patients with Parkinsons disease experiencing OFF episodes
The US Food and Drug Administration has approved Adamas Pharmaceuticals Gocovri for a new indication in patients with Parkinsons disease experiencing OFF episodes.
The FDA has approved Gocovri as an adjunctive treatment to levodopa/carbidopa, a commonly-used treatment for the main symptoms of Parkinsons disease.
When Parkinsons progresses, individuals receiving levodopa-based therapy often experience the return of symptoms including stiffness, rigidity and tremors referred to as OFF episodes between medication doses.
Although the primary treatment for Parkinsons is levodopa, over time treatment with this drug can cause involuntary and uncontrolled movements referred to as dyskinesia.
In addition to this new indication approval for use in treating OFF episodes, Gocovri is approved to treat dyskinesia in Parkinsons patients receiving levodopa/carbidopa therapy.
In two phase 3 clinical studies, Gocovri treatment was shown to significantly reduce both OFF time and dyskinesia.
Gocovri treatment also resulted in a clinically meaningful increase in good ON time referring to when levodopa is working well and symptoms are controlled.
In addition, Adamas drug demonstrated sustained efficacy for at least two years in the phase 3 EASE LID-2 trial.
Gocovri is now the first and only medication approved to treat both OFF and dyskinesia motor complications in Parkinsons disease, he added.
Causes Of Parkinson’s Disease
The causes of Parkinsons disease are still greatly unknown. Scientists who have studied this disorder estimate that 10-15% of cases come from genetics after seeing a series of genetic mutations that were common in Parkinsons patients.
Doctors suspect that environmental factors and lifestyle choices may have effects on the severity of Parkinsons disease symptoms. Exposure to chemicals like pesticides may increase the likelihood of developing Parkinsons disease. On the other hand, a good diet and regular exercise may decrease your chances.
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Parkinsons Surveys Clinical Trials And Volunteer Opportunities
PAIRing Up If you are a person with Parkinsons or a care partner to someone with Parkinsons, you are invited to participate in an online survey to address neuropsychiatric concerns in Parkinsons. The survey aims to learn about the needs and priorities for clinical care, education, support, and research as related to neuropsychiatric symptoms. To learn more and participate, .
The University of Oulu, along with collaborators from Aalborg University, Fraunhofer University, the University of Manchester, the University of Glasgow, the University of Lisbon, and the University of Melbourne, is conducting a survey for people with Parkinsons and Parkinsons care partners about self-care. Complete the survey here to share your self-care strategies and techniques. You can also review ideas submitted by others and add them to your own self-care toolbox.
Looking for a once-in-a-lifetime adventure? Pass to Pass, a nonprofit dedicated to raising Parkinsons awareness while supporting hikers living with Parkinsons, offers multi-day hiking trips on the Pacific Crest Trail in both Washington and Oregon. Participants are being recruited now for these summer 2021 events. For more details and information, visit www.PasstoPass.org or contact Bill Meyer at 509-991-1212 or .
Park Test University of Rochester
Project Euphonia LSVT Global and Project Euphonia
The Latest In Parkinsons Medications: Taking A Personalized Approach
From renowned singer Linda Ronstadt to former NBA player Brian Grant, the faces of Parkinsons disease are as diverse as the symptoms. While there can be common themes such as slowed movement or stiffness each persons PD experience is unique, making individually tailored therapy vital. Fortunately, the list of medications and treatments that improve quality of life for people living with PD continues growing.
This article is based on a Parkinsons Foundation Expert BriefingParkinson’s Disease & Medication – What’s Newpresented by Vanessa K. Hinson, MD, PhD, Movement Disorders Program director, Medical University of South Carolina, a Parkinsons Foundation Center of Excellence.
Parkinsons disease can vary widely from one person to another. Whether or when someone might experience rapid, involuntary and uncontrollable body movements, called dyskinesias, as a complication of some Parkinsons medications can also fluctuate. Cognitive changes or multitasking can pose challenges for some who live with PD, while others might experience hallucinations. Optimal PD treatment and care should be based on your unique symptoms and help you to live your best life.
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Meditation And Relaxation Techniques
Meditation and relaxation techniques can take many forms. Listening to relaxing music is the most basic form. Mindful meditation can be used to relax and focus on breathing or negative emotions and thoughts. It can also be used to help a person become more aware of their surroundings or body movements. Several studies have shown a connection between Parkinsons disease symptoms and mindful meditation.
Selective D1 Receptor Agonists
Selective D1 agonists have received a resurgence of attention over the last 3 years. As derivatives of catechols, all known selective D1 agonists exert short duration effects, because they are rapidly metabolized and desensitize D1 receptors after prolonged exposure . Recently, potent noncatechol selective D1 agonists with good in vivo efficacy and promising pharmacokinetic properties were identified . PF-2334 , a G-protein-biased D1 agonist, shows sustained plasma concentrations and induces robust in vivo pharmacological responses without functional tachyphylaxis. The oral administration of PF-2334 has potent in vivo effects both on eye-blink responses in nonhuman primates and in a unilateral 6-OHDA lesioned rodent model of PD. On the other hand, 10 , a balanced agonist with highly potent effects on both signaling pathways, also displays satisfactory PK profiles, including good BBB penetrance. Importantly, 10 displays in vivo anti-Parkinsonian activity, restoring locomotion and prodyskinetic potential while potentiating behaviors indicative of dyskinesia in a 6-OHDA-lesioned mouse model of PD.
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Lifestyle Tips For Parkinsons Disease
Treatment for PD goes beyond medications and physical therapy. People living with PD can also benefit from:
Regular exercise. People who begin exercising after their Parkinsons diagnosis have improved quality of life. In fact, just 2.5 hours of exercise per week can make a difference.
Healthy diet and weight. People with PD can unintentionally lose weight. This is because eating and chewing become more difficult. Learning to prepare softer foods rich in nutrients and calories can be helpful in preserving weight and strength.
Mental health treatment. About 50% of people with PD will experience depression at some point after their diagnosis. Talk therapy, support groups, and antidepressants can help with changes in mood, feelings of sadness, or anxiety.
Caregiver support. Social workers can help families with health services, financial challenges, and insurance options to cover needed equipment.
New Medications For Off Time
A number of new medications approved recently are designed to reduce OFF time. These medications fall into two major categories:
- Medications that lengthen the effect of a carbidopa/levodopa dose
- Medications that are used as needed if medication effects wear off
Well give specific examples below. In general, new medications that extend the length of a carbidopa/levodopa dose are used if OFF time is somewhat predictable and occurs prior to next dose. New medications that are used as needed are most beneficial when OFF time is not predictable.
New medications that lengthen the effect of a dose of carbidopa/levodopa
- Istradefylline is an adenosine A2A receptor antagonist which was approved in the US in 2019 as an add-on therapy to levodopa for treatment of OFF time in PD. Unlike many of the other medications, it has a novel mechanism of action and is the first medication in its class to be approved for PD. It acts on the adenosine receptor, which modulates the dopaminergic system, but is not directly dopaminergic. The drug was developed in Japan and underwent clinical trials both in Japan and in the US.
- Opicapone is a catechol-O-methyltransferase inhibitor that is taken once a day. It was approved in the US in 2020 as an add-on therapy to levodopa for motor fluctuations.
New formulations of levodopa designed to be used as needed if medication effects wear off
Other medications used as needed if medication effects wear off
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How We’re Speeding Up The Search For A Cure
We believe that new and better treatments are possible in years, not decades, and we have a clear strategy for making this happen. This includes:
- backing the best and brightest minds to unlock scientific discoveries that will lead to new treatments and a cure
- accelerating the development and testing of new treatments through our Virtual Biotech
- collaborating internationally to make clinical trials faster, cheaper and more likely to succeed through the Critical Path for Parkinson’s
Medications To Avoid Or Use With Caution
Sign up for our email list and receive our publication on medications with potential complications you should be aware of.
Before making any decisions about treatment of Parkinsons disease, you will want to learn about the different types of medications available for Parkinsons disease and discuss the pros and cons of each with your physician. It may help to know that there is no right answer, and if you try something that doesnt work for you, you can always adjust your plan.
To learn more about adjusting medication plans, view our webinar on What to Do When Your Medications Stop Working.
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Phase One To Phase Two
Nineteen Australian Parkinsons patients were recruited for the trial, and 18 were administered the drug, in three different volumes: Small, medium and large.
Dr Evans said he expected to see at best the participants disease remain at the same level.
What he observed surprised him.
But it was shown not only that people got better, they improved in signs and symptoms of Parkinsons, Dr Evans said.
This was more marked in higher-dose groups, who were given 72 milligrams of the drug a day.
I was playing it down to patients at the start, saying, This probably wont make you feel better. But people were coming back saying, I feel better on this drug.
Dr Evans theorised the drug was effective because of the way it activated affected neurones.
In Parkinsons disease, some neurones are dead, and some are sick, while some remain functioning.
What the drug has done is bring back those sick neurones into functioning well, he said.
With just a couple of final assessments to be made in phase one, researchers are already looking to phase two, which will involve more trials over longer periods of time and larger control groups.
The challenge in Parkinsons is that it is a very slowly progressing disease, Dr Evans said.
if youre just slowing the progress of the disease, you do need to study people for longer.
But if this drug holds up maybe we can get in a shorter amount of time.
Updates On The Clinical Progress Of Dopaminergic Pd Treatments
Despite the intensive efforts in PD research and development, there are clear unmet medical needs for the development of additional dopaminergic treatment options to improve current DA-centered treatment. Most currently used dopaminergic drugs selectively activate D2-like DA receptors , but no D1-like selective agonists have been successfully approved even though the D1 receptor is a known target for PD treatment. Recently, important progress has been made in the clinical development of D1 selective agonists and allosteric modulators. All active dopaminergics since 2012 on the clinical trial website are summarized in Fig. and Table .
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Australian Trial Gives New Hope For Parkinsons Disease Treatment
Theres quiet but confident hope for a breakthrough treatment for Parkinsons disease, following a successful drug trial in Australia.
It ticked two boxes when it comes to treating the debilitating degenerative disease: Improved patient symptoms and it stopped the progression of Parkinsons.
The drug involved is called CuATSM, and targets affected brain cells through a copper capsule, taken orally, which was taken three times daily by patients over the course of six months.
It was developed in Victoria at the Florey Institute of Neuroscience and Mental Health, in conjunction with the University of Melbournes Bio21 Institute. The trial was delivered by the Royal Melbourne Hospital.
The hospitals Andrew Evans said the drug had also proven effective in trials with motor neurone disease patients, the results of which were released in January.
Dr Evans told The New Daily the Parkinsons trial while he was cautious to temper the results gave a lot of promise for future, broader treatments to come.
It shows quite a lot of hope, he said.
Procedures For Parkinsons Disease
In later stages of PD, electric devices called deep brain stimulators may be helpful. These small devices are implanted in the brain and deliver painless electrical signals that help stimulate brain function. DBS can treat people with severe tremors and uncontrolled movements. Importantly, it doesnt affect dopamine levels in the body. This means that it doesnt lead to the unwanted side effects related to increasing doses of medications.
There are additional, less common procedures that are also an option for people in later stages of PD. These procedures, called lesioning procedures, use high energy beams to intentionally destroy targeted areas of the brain that contribute to tremors. This may be an option if you have a severe tremor that medication cant control when DBS isnt a safe option.
Scientists are also working on a treatment that regenerates brain cells that are lost in PD. But this is still under development.
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