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FDA Approves Medtronic’s Percept PC Deep Brain Stimulation System

Nuplazid NDA

The U.S. Food and Drug Administration (FDA) has approved the Percept PC Neurostimulator by Medtronic, designed to allow for a more individualized use of deep brain stimulation therapy in people with Parkinson’s disease and related disorders.

While this device is the fourth deep brain stimulation (DBS) system to be approved in the U.S., it is the first system able to sense and record brain signals while therapy is delivered. As such, it is expected to help doctors more precisely tailor treatment to a patient’s needs.

“Percept uses BrainSense technology, which captures brain signal data from implanted brain leads, combined with a patient diary system,” Joohi Jimenez-Shahed, MD, professor of neurology at Icahn School of Medicine at Mount Sinai, said in a news release by the Michael J. Fox Foundation.

“This device allows us to measure and record brain signals, which can be matched with a person’s symptoms as reported in the diary or what we see on exam. By looking at brain signals, we might be able to tell whether symptoms relate to medication wearing off or to dyskinesia, for example, and we can use this information to more precisely understand how a patient’s symptoms respond to DBS,” Jimenez-Shahed said.

“Eventually, we hope to be able to use this data to adjust DBS settings for more tailored and targeted treatment,” she added.

DBS is used to treat neurological disorders that include Parkinson’s, essential tremor, dystonia, epilepsy, and obsessive-compulsive disorder. Therapy is delivered via a small, implantable device that is somewhat similar to a pacemaker. Tiny wires inserted in the brain are used to send electrical signals from the device to specific brain regions, aiming to ease motor symptoms.

Percept is also the first approved DBS system that can be used in certain full-body MRI scans, allowing greater access to imaging for patients and clinicians, Medtronic reports in a press release.

The first U.S. center to implant the device will be the Mayo Clinic in Rochester, Minnesota, it added.

“Our goal is for patients to regain independence, and we know that DBS can significantly improve motor function in people with Parkinson’s disease compared to standard medication alone,” said Bryan Klassen, MD, a neurologist at the Mayo Clinic.

“As with any therapy, considering DBS and choosing between specific devices is about weighing pros and cons,” Jimenez-Shahed said. “Because Percept is a new approach, doctors and patients will learn together in the months ahead who are the best candidates for the new technology and the best ways to take advantage of what it has to offer.”

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Supernus Acquires Apokyn and Xadago from US WorldMeds

acquisition news

Supernus Pharmaceuticals’ acquisition of US WorldMeds’ portfolio of central nervous system (CNS) disease treatments adds two established Parkinson’s disease (PD) therapies and a leading investigative product to its neurology portfolio.

The deal calls for a $300 million upfront cash outlay, plus $230 million in milestone payments for the Parkinson’s treatments Apokyn (apomorphine) and Xadago (safinamide).

Supernus also acquired the company’s Apomorphine Infusion Pump, which, if approved by the U.S. Food and Drug Administration (FDA), would allow for a continuous subcutaneous (under the skin) apomorphine infusion.

“This acquisition aligns extremely well with our strategy of expanding and enhancing our commercial and late-stage assets and is a significant step in strengthening our leadership position in CNS,” Jack Khattar, Supernus’ president and CEO, said in a press release.

It also “brings new research and development platforms to Supernus in biologics and medical devices. We look forward to building on the success that US WorldMeds had in establishing this portfolio of unique products.”

Apokyn is given by injection between doses of the levodopa to treat a loss of body movement control in patients with advanced Parkinson’s. It has the same effect as dopamine, a naturally occurring chemical messenger in the brain that is gradually lost in the disease.

Several years after starting levodopa — a gold standard in care — most patients begin experiencing motor symptom fluctuations caused by a faster wearing off of the treatment’s effects. These “off” episodes can happen at any time of the day, and most patients experience more than one episode daily. In a Michael J. Fox Foundation survey of 3,000 patients, more than 90 percent reported having at least one “off” episode daily, and nearly 65 percent experienced such episodes for at least two hours.

Apokyn does not prevent off episodes, but it does help to improve symptoms when an episode has begun.

Xadago is an oral once-daily add-on therapy developed to improve motor function in Parkinson’s patients experiencing off periods. It works through the selective and reversible inhibition of the enzyme monoamine oxidase B, which increases functional dopamine levels. It also blocks voltage-dependent sodium channels, which regulate the release of abnormal glutamate, a neurotransmitter in the brain involved in nerve cell communication. The treatment is available in several countries, including the United States.

If approved by the FDA, the Apomorphine Infusion Pump would offer Parkinson’s patients a less-invasive and more convenient way to administer Apokyn. The device would provide a continuous subcutaneous infusion of the medication.

Supernus is expected to submit an application to the FDA requesting approval this year, likely supported by findings in a Phase 3 trial of the pump’s use (NCT02339064) in patients. If approved, the product could launch in the second half of 2021.

“The core values of Supernus align very well with US WorldMeds,” said Paul Breckinridge Jones Sr., CEO of US WorldMeds. “We expect a seamless transition with even more patients benefiting from these products under Supernus’ stewardship. This transaction will allow US WorldMeds to focus on growing our other exciting business units.”

This CNS portfolio, which includes the cervical dystonia therapy Myobloc (rimabotulinumtoxinB), had net sales last year of about $150 million. Under the agreement, Supernus will also gain a sales team with expertise in serving movement disorder specialists in the U.S.

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FDA Names Spectramax Light Therapy ‘Breakthrough Device’ for Parkinson’s

FDA designation

The United States Food and Drug Administration (FDA) has granted breakthrough device designation to PhotoPharmics‘s light-based, at-home device as an add-on therapy for Parkinson’s disease.

This designation is given to medical devices with the potential to offer more effective treatment for life-threatening or debilitating diseases. It grants the company access to experts at the FDA during development, and paves the way for prioritized review of approval requests.

In addition to its motor symptoms, Parkinson’s is characterized by non-motor symptoms that can occur several years before difficulties with movement and muscle control begin to emerge. These include cognitive impairment, sleep disturbances, depression, and pain.

The circadian rhythm — our body’s “natural clock” that regulates essential functions such as sleep or metabolism — is known to be poorly regulated in people with Parkinson’s. That dysregulation is associated with the development of both motor and non-motor disease symptoms.

PhotoPharmics’s device is based around light therapy, or phototherapy, and uses a combination of light intensities and bandwidths believed to have therapeutic effect. Preclinical work suggests that light therapy can improve the circadian rhythm, and help ease disease symptoms.

A clinical trial (NCT02175472), sponsored by PhotoPharmics, treated 92 Parkinson’s patients — ages 45 or older, and all on stable dopaminergic therapy — with either its light therapy device or a placebo light for one hour each evening for six months.

Results, released in late 2018 and based on scores reported by both patients and doctors, showed an easing in disease severity, lesser non-motor symptoms, and improved quality of life among those given the light therapy.

“Very few device companies receive Breakthrough designation. Our device is the first specialized phototherapy device ever to achieve this status,” Kent Savage, PhotoPharmics’s chief executive officer, said in a press release. “We believe this is largely due to the improvements we saw in non-motor symptoms” in this trial.

“Since there is no known cure for Parkinson’s disease, our mission is to help people recover function and return to what they enjoy doing most. This recognition … validates our work,” Savage added.

PhotoPharmics is currently engaged in a financing round to support a planned pivotal clinical trial of its Celeste phototherapy device (based on its Spectramax technology) in treating Parkinson’s.

The proposed Phase 3 trial is expected to begin enrollment of up to 200 patients in August. Those interested in participating, or in learning more about the company and this device, can sign up for information on its website.

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FDA Grants Breakthrough Device Designation for nQ Medical’s neuroQWERTY

nQ

The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to nQ Medical’s neuroQUERTY software, which is designed to monitor brain health and Parkinson’s disease progression.

Breakthrough device status is given to medical devices that have the potential to be an effective treatment or diagnostic tool for life-threatening or irreversibly debilitating diseases. The status speeds the review and assessment process so the devices can reach the market faster.

“The breakthrough device designation reaffirms that the nQ’s brain monitoring solution enables better treatment of patients by providing more precise and timely feedback to clinicians,” Rahul Mahajan, MD, chief medical officer of nQ Medical, said in a press release.

The neuroQWERTY software measures how fast a person is typing on a smart device and how much pressure they apply to each key. An artificial intelligence method called machine learning can detect small changes in the typing movements, which it can associate with different diseases such as Parkinson’s. The software does not record the words that were typed, only the patterns associated with the typing action.

“Everyone has a unique typing and touchscreen signature. Research has revealed that the way we interact with computers and mobile devices can reveal with startling accuracy the presence of certain neuromotor, neurocognitive, and neurobehavioral disorders,” said R.A. Bavasso, co-founder and CEO of nQ Medical.

NeuroQWERTY can be used with any keyboard, tablet or smart phone. This allows for round-the-clock monitoring of disease progression and treatment effectiveness without going to the clinic. This is a significant improvement from the current standard of care where patients see movement disorder specialists only once or twice a year.

“Just live your life as you normally do with your chosen personal device and we can collect and feed back to you and your physician the status of your brain health,” Bavasso said.

The software could speed diagnosis of neurodegenerative diseases, which would lead to earlier intervention and better clinical outcomes. The effect of new and existing therapies also can be monitored more closely, allowing doctors to quickly understand which treatment works best for each patient.

The nQ platform was developed at the Massachusetts Institute of Technology and funded partly by the Michael J. Fox Foundation, with the goal of creating an artificial intelligence tool to diagnose and monitor disease progression and track therapeutic effectiveness.

Five studies using neuroQWERTY have been published and five clinical trials have assessed this technology so far.

One clinical trial (NCT02522065) evaluated the use of the neuroQWERTY approach in an uncontrolled at-home setting, by analyzing the baseline data collected from participants who were diagnosed less than five years ago and were about to initiate dopaminergic therapy.

The technology was able to distinguish Parkinson’s patients from healthy individuals through the analysis of at-home typing patterns, and had a comparable performance to that performed in the clinic.

Another trial (NCT04101968) is currently using neuroQWERTY as one of its diagnostic tests to link the relationship between gamma-aminobutyric acid (GABA) mutations — known to increase the risk of developing Parkinson’s— and Parkinson’s disease.

The trial may help researchers understand the changes that take place in the brain of people with GBA-related Parkinson’s disease, especially during the early stages of the disease.

That study is still recruiting participants. More information can be found here.

More trials are planned in mild cognitive impairment (MCI), amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and concussion (mTBI, or mild traumatic brain injury).

“The FDA’s recognition of enabling novel and effective digital therapies that demonstrate clinical evidence benefits helps the thousands of sufferers of Parkinson’s disease,” Mahajan said.

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Imaging Analysis Software QyScore Receives FDA Clearance

QyScore software

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Qynapse‘s QyScore, a software that aids in analyzing brain scans taken by magnetic resonance imaging (MRI).

The software, which is compatible with routine imaging workflows, includes an advanced user interface and automatically-generated patient reports. Results are presented in comparison to data on people without known brain disease, giving neurologists and radiologists support in making clinical interpretations and decisions for treatment in a number of conditions, including Parkinson’s disease, multiple sclerosis, and Alzheimer’s disease.

In addition to aiding in diagnostics and monitoring disease progression, the software has been employed in clinical trials to help measure responses to treatment and safety profiles for investigational therapies.

Doing this kind of imaging analysis with a computer program, rather than relying on humans to interpret images, helps cut down on costs and time associated with the analyses. It also reduces variability in interpreting results. This includes both person-to-person variability and variability that can occur for the same person reading images at different times, since the computer is not subject to the same variances that can affect human scorers.

“QyScore makes a difference for the diagnosis of dementias at an early stage of the disease when it remains a challenge,” Bruno Dubois, PhD, said in a press release. Dubois is a professor at Sorbonne University and director of the Memory and Alzheimer’s Disease Institute at Pitié Salpêtrière Hospital in Paris. “The automatic quantification of markers such as brain atrophy, white matter hyperintensities and more, provides highly valuable help to support a timely diagnosis and an efficient monitoring of disease progression,” he said.

QyScore was first commercialized in Europe after receiving CE mark approval in September 2017.

To obtain 510(k) clearance for a new medical device, a company must submit technical, safety, and performance information for that device to the FDA. The FDA then reviews this data and, if appropriate, clears the device for sale in the U.S.

“FDA clearance is a major milestone to expand the commercialization of the software within the U.S.,” said Olivier Courrèges, CEO of Qynapse. “Qynapse will accelerate collaboration with experts and healthcare providers in the U.S. to pursue its journey for better patient care in neurology.”

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FDA Response Bolsters Affiris’ Plans for Potential Parkinson’s Vaccine Affitope

Affitope response

The U.S. Food and Drug Administration (FDA) has responded to Affiris‘  pre-investigational new drug (IND) submission regarding a planned Phase 2 clinical trial of the potential Parkinson’s vaccine Affitope (PD01A).

After reviewing previous preclinical and clinical data, the FDA answered questions posed by the company and provided guidance related to designing the upcoming trial.

Based on that response, Affiris intends to initiate the Phase 2 study in the U.S. and Europe in the second half of this year.

In the brains of people with Parkinson’s disease, the protein alpha-synuclein forms into spherical clumps called Lewy Bodies, which are toxic to neurons. It is widely believed that therapies that reduce this accumulation of alpha-synuclein could be beneficial for Parkinson’s.

Affitope is designed to induce the body’s immune system to make antibodies — molecules that recognize specific targets — against alpha-synuclein. By encouraging one’s body to develop its own defenses against molecules that contribute to Parkinson’s, Affitope works like a vaccine against the disease.

In theory, this could cause the immune system to reduce alpha-synuclein, without the need for repeated administration of medication.

The experimental therapy was previously tested in a series of Phase 1 clinical trials in patients with Parkinson’s disease (NCT01568099NCT01885494NCT02618941NCT02758730, and NCT02216188). Results showed Affitope was well-tolerated, with the only reported treatment-related adverse side effects being mild injection site reactions. Lab tests also showed that the vaccine did trigger the production of antibodies against alpha-synuclein.

Those early trials were not designed to detect a change in Parkinson’s symptoms.

Details of the planned Phase 2 trial. trial design and objectives have not yet been released by Affiris, but in general, Phase 1 trials are designed primarily to evaluate safety, whereas Phase 2 trials are more concerned with finding appropriate dosages and obtaining preliminary data on effectiveness.

“We are pleased to have completed the pre-IND process, with the FDA providing helpful guidance for the continued advancement of Affitope PD01 for the treatment of Parkinson’s disease, an indication with an urgent and significant unmet medical need,” Noel Barrett, PhD, CEO at Affiris, said in a press release. “We appreciate the FDA’s feedback as we endeavour to provide patients with a potentially disease-modifying immunotherapy utilizing our proprietary patented Affitome technology.”

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FDA Extends Abbott’s Infinity DBS System Approval to Target Additional Brain Region

Infinity DBS system

The U.S. Food and Drug Administration (FDA) has expanded Abbott’s Infinity Deep Brain Stimulation (DBS) system approval to target a brain region critical for motor functions — the globus pallidus — as a way to lessen motor symptoms in Parkinson’s disease patients who still show impairments after medication.

This extended approval makes Abbott’s Infinity the only directional DBS system approved to target all three main brain regions used to treat Parkinson’s, essential tremor and movement disorders: the globus pallidus, the subthalamic nucleus, and the ventral intermediate nucleus.

DBS is an invasive surgical technique in which thin wires are implanted in the brain to deliver electrical pulses to certain areas. It is intended to ease motor symptoms in patients for whom standard medications, such as levodopa, are not effective, and stave off long-term motor complications, including tremors and dyskinesia (involuntary movements).

Traditional DBS systems are “omnidirectional,” meaning they don’t target specific parts of the brain. Abbott’s DBS system differs from others in that it’s designed to steer electrical current toward specific parts of the brain to lessen symptoms such as tremors.

Because the stimulation is more targeted, patients should be able to get meaningful symptom relief with less stimulation.

“The internal segment of the global pallidus, or GPi, is a well-established valuable DBS target for the management of the motor signs associated with Parkinson’s disease, and is a preferred target for many patients, particularly for those with troublesome medication induced dyskinesia,” Jerrold Vitek, MD, PhD, said in a press release. Vitek is director of the University of Minnesota Udall Center of Excellence for Parkinson’s Research, .

The Infinity DBS system uses a wireless Apple consumer device that allows doctors to perform upgrades and optimize programming settings without the need for surgery. Patients also are able to control their Infinity DBS System via a wireless touch controller.

“This approval expands the options for patients to tailor treatment to their unique needs, with the added benefits of being able to target precise areas and utilizing a patient-friendly iOS device,” Vitek said.

The ongoing PROGRESS trial (NCT02989610) is evaluating Abbott’s Infinity DBS system for treating Parkinson’s. The trial’s primary goal is to compare the therapeutic effectiveness of the Infinity DBS system compared to a conventional omnidirectional system.

Preliminary results from 66 Parkinson’s patients evaluated after three months of using the Infinity DBS system showed that most (89.4%) had a wider therapeutic window — an average increase of 35% — accompanied by an average decrease of 30% in the amount of stimulation needed to attain a therapeutic effect, compared with patients who were using a conventional omnidirectional system.

“Abbott’s PROGRESS study has led the way in establishing the value of directional DBS systems for targeted areas of the brain,” said Binith Cheeran, MD, director of medical affairs, deep brain stimulation, at Abbott.

“The approval of Abbott’s Infinity DBS system with targeted stimulation is a significant advancement for people living with Parkinson’s disease and their care teams. The ability to optimize the programming for each individual opens the door for a new standard of care for DBS therapy,” he said.

Abbott’s Infinity DBS system is available in nearly 30 countries.

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RightEye’s Vision System for Early Diagnosis Named ‘Breakthrough Device’ by FDA

RightEye system

RightEye’s Vision System, an advanced eye-tracking device that measures eye tremors to help diagnose Parkinson’s disease at early stages, has been designated a breakthrough device by the U.S. Food and Drug Administration.

This FDA designation is given select medical devices or products that aim to more effectively treat or diagnose ” life-threatening or irreversibly debilitating diseases.” It streamlines processes to speed these devices’ development, testing, and agency review for approval, possibly allowing them to reach the market more quickly.

Currently, a Parkinson’s diagnosis relies on the outcomes of several neurological tests, and delays are common before a correct decision is reached.

“When assessing Parkinson’s disease, 60% of patients are misdiagnosed at least once, with one third of patients misdiagnosed twice. That is a terrifying and unacceptable statistic in the age of modern medicine,” George Gitchel, PhD, director of clinical research at the Southeast Parkinson’s Disease Research, Education, and Clinical Center (PADRECC), at the Richmond Veterans Affairs Medical Center, said in a press release.

“In my experience Parkinson’s patients often struggle for years, going from doctor to doctor trying to get a correct diagnosis,” Gitchel added.

Previous research has found tremors that prevent the eyes from fixing with stability are “pervasive” in people with Parkinson’s, and researchers have suggested that eye tremor be considered in diagnosing the disease.

The RightEye Vision System uses advanced eye-tracking technology to measure eye tremors, which usually develop in patients before other symptoms arise. This means that the device may help to detect Parkinson’s at early stages.

The size of a laptop, the system provides objective and accurate visual screening, generating reports that reflect hundreds of collected metrics.

“By providing quantitative, objective data to assist clinicians, I truly believe that RightEye will play a key role addressing this issue, while its FDA Breakthrough Designation will accelerate availability,” Gitchel said.  

The system received FDA clearance  for recording, viewing, and analyzing eye movements to help identify patients with troubled visual tracking in October 2018.

“With this FDA Breakthrough Device Designation, RightEye has an opportunity to address a critical unmet need in the fight against Parkinson’s disease,” said Adam Gross, co-founder and CEO at RightEye.

“The annual cost of Parkinson’s disease in America is estimated at approximately $52 billion. Earlier assessment, intervention, and more accurate diagnoses is anticipated to reduce these costs, while also improving patient outcomes and quality of life,” he added.

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New Large-Scale Data Portal Will Promote Parkinson’s Treatment Development

data portal

The Accelerating Medicines Partnership (AMP) for Parkinson’s (PD) has opened a data portal with de-identified information from 4,298 Parkinson’s patients and healthy control subjects for use by scientists seeking new treatments for the progressive neurodegenerative disease.

With unprecedented access to a data pool of this scale, investigators now can examine intricate data sets and conduct full-scale genomic analyses.

“AMP PD is a true example of the whole being greater than the sum of its parts,” said Walter Koroshetz, MD, director of the National Institute of Neurological Disorders and Stroke (NINDS), in a press release. “The combination of many data sets could allow researchers greater power to analyze potential biomarkers for Parkinson’s disease. This effort follows other AMP programs which have the shared goal of changing the way we go about the business of studying disease.”

Launched in 2014, the AMP is a public-private partnership between the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), multiple biopharmaceutical and life sciences companies, and non-profit organizations. Its goal is to transform the current model for developing new diagnostics and therapies by collaboratively identifying and validating promising biological treatment targets. The overarching mission is to develop new diagnostics and therapies relatively faster and at less cost.

Initial projects included Alzheimer’s disease, Type 2 diabetes, and rheumatoid arthritis, and lupus.

Last January, the AMP project on PD was launched. Managed by the Foundation of the National Institutes of Health (FNIH), the project includes the NIH, FDA, the Michael J. Fox Foundation (MJFF) for Parkinson’s Research, Celgene, Verily Life Sciences, Pfizer, Sanofi and GSK.

This project’s aim is to speed therapy development by providing the expertise and support necessary to learn which biomarkers demonstrate the most promise for predicting PD and disease progression. Biomarkers are molecular disease indicators.

“One important part of this platform is that, in addition to providing a place for storing complex data, we are also providing the tools to analyze that data within the platform itself,” said Debra Babcock, MD, PhD, NINDS program director and co-chair of the AMP PD steering committee. “In this way, we are bringing scientists to the data, which will increase opportunities for collaboration.”

Data in the officially named AMP PD Knowledge Portal was collected through the MJFF, NINDS and several other programs, studies and institutions. It includes information from samples of DNA, RNA, plasma, and cerebrospinal fluid, which is the liquid that surrounds the brain and spinal cord. The portal also offers a platform that can assimilate additional types and sources of data. For example, there is an upcoming study involving proteomics, the large-scale study of proteins.

With the longitudinal data in the portal, scientists can study patients’ information throughout the disease course. And, the data have been harmonized, allowing for comparison of information from different programs, and providing best practices for how to incorporate into the platform data from the PD community.

“The AMP model has provided a unique platform for bringing together diverse patient cohorts, advances in technology and scientific expertise to study Parkinson’s disease on a scale that has not been attempted before,” said David Wholley, senior vice president, research partnerships, FNIH. “With the AMP PD Knowledge Portal, we are helping the scientific community worldwide to fast-track discoveries that we hope will ultimately help Parkinson’s disease patients and their families.”

Scientists may visit this site to apply for access to the knowledge portal and interact with the data set.

Globally, roughly 7 to 10 million individuals have Parkinson’s, the second most common neurodegenerative disorder after Alzheimer’s disease.

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Nourianz Now Available in US as Add-on to Carbidopa/Levodopa to Treat Parkinson’s Off Periods

Nourianz tablets

Kyowa Kirin’s Nourianz (istradefylline) tablets are now available in the United States as an add-on treatment for off periods in Parkinson’s disease patients on a carbidopa/levodopa regimen.

Off periods — when the effects of a medication wear off before a new dose can be taken — are characterized by the re-emergence of Parkinson’s motor symptoms and are typically more common as the disease progresses. Within five years of starting levodopa/carbidopa therapy, approximately 50% of patients may experience off periods.

“We are pleased to offer patients Nourianz, the first and only FDA-approved adenosine A2Areceptor antagonist treatment for ‘off’ time associated with [Parkinson’s],” Tom Stratford, president of Kyowa Kirin USA Holdings, said in a press release. “Nourianz administered with levodopa/carbidopa therapy can help reduce ‘off’ time and increase ‘on’ time without troublesome dyskinesia.”

Nourianz blocks a receptor, known as the adenosine A2A receptor, found at high levels in the basal ganglia, a region of the brain that controls movement. By blocking this receptor, Nourianz can alter the release of neurotransmitters — chemical substances produced in response to nerve signals that allow nerve cells to communicate — in the basal ganglia, regulating motor activity.

The U.S Food and Drug Administration (FDA) approved Nourianz in August based on the results of four randomized, placebo-controlled Phase 2 and 3 clinical trials (NCT00955526, NCT00455507, NCT01968031, and NCT00250393).

The trials assessed the safety and efficacy of two doses (20 mg and 40 mg) of Nourianz to reduce the mean total hours of awake time per day spent in the off state and also lessen motor symptoms.

A total of 1,143 Parkinson’s patients taking levodopa/carbidopa, levodopa/benserazide, or levodopa and any other dopa-decarboxylase inhibitor were recruited. Treatment with Nourianz significantly decreased daily off time, compared with patients on a placebo, and improved motor function.

The most common side effects of Nourianz included involuntary muscle movement (dyskinesia), dizziness, constipation, nausea, hallucinations, and insomnia.

“In my clinical practice, I see patients who experience the troublesome effects of Parkinson’s disease and ‘off’ episodes that interfere with activities of daily living,” said Peter A. LeWitt, MD, a professor of neurology at Wayne State University School of Medicine and director of the Parkinson’s Disease and Movement Disorders Program, Henry Ford Hospital.

“Nourianz represents an important milestone and provides U.S. patients and their caregivers with a nondopaminergic, once-a-day oral treatment option to significantly decrease the amount of ‘off’ time,” LeWitt added.

Nourianz has been marketed in Japan under the brand name Nouriast since May 2013.

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