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‘Framing OFF Through Art’ Exhibit on View at World Parkinson Congress

Artworks focus on off periods

More than 1 in every 3 — some 40 percent — of Parkinson’s patients have “off periods,” the return of motor and non-motor symptoms as the effectiveness of a  treatment’s dose wears off. Artworks created in collaboration with patients, part of an Acorda Therapeutics program, are helping to express what these periods are like and focus attention on them.

Called Framing OFF Through Art, the six-piece exhibition was recently featured at the 5th World Parkinson Congress in Kyoto, Japan, attended by more than 3,000 people from at least 60 countries. The initiative is the centerpiece of Acorda’s Live Well. Do Tell program, launched last year.

Off periods are characterized by the re-emergence of Parkinson’s symptoms, such as sadness and anxiety, when the effects of levodopa/carbidopa wear off. Such episodes are typically more common as the disease progresses, and vary from person to person.

Because off periods can be difficult to discuss or even identify, the artwork is intended to visualize feelings associated with them. The hope is that the art will spur other patients to recognize their “off” symptoms, and discuss them with their care team. The artists who created the pieces have been touched in some way by Parkinson’s.

”Research has consistently shown that off periods are among the most common issues for people living with Parkinson’s disease,” Ron Cohen, MD, Acorda president and chief executive officer, said in a news release.

“We believe that people with Parkinson’s will be able to see aspects of their own experiences with Parkinson’s and off periods in these works of art.”

The artwork ranges from acrylic sculptures to oil paintings. Each artist was paired with two patients and their caregivers. The exhibition debuted in October at a New York event where the artists, patients and caregivers were guests. The need to better understand off periods, as well as how to discuss them, is highlighted in the Live Well. Do Tell statement of need.

As part of a rotating series, a piece called “Rooted Resilience” is featured on the Live Well. Do Tell website. Created by abstract impressionist and colorist Tim Kinney, who has several friends with Parkinson’s, the multi-color painting of a tree depicts the way Gustavo Pavon, diagnosed in 2006, described his off periods.

The painting’s transition from dark roots to the brightness of the leaves and sky is meant to illustrate emergence from an off time.

Marcela Del Bosque, Pavon’s wife and caregiver, is mentioned in a narrative accompanying the painting as describing the transition in this way:

“When Marcela saw the painting, she immediately picked up on this and noted that when Gustavo is in a dark place — in an off period — he’s quiet and doesn’t smile. Then, Gustavo’s bright smile that she loves reappears and he returns.”

The work’s branches and colors also symbolize Pavon’s growth — his “branching out” —  to embrace community support and speak more openly about his experience. For nearly a decade, Pavon had only told a few people about his condition and off symptoms that include shivering and stiffness.

Go here to learn more about off periods and for additional resources.

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Inbrija Approved in US to Treat Off Periods in Parkinson’s Patients on Carbidopa/Levodopa

Inbrija

The U.S. Food and Drug Administration has approved Inbrija (levodopa inhalation powder)‎ for the treatment of Parkinson’s off periods in patients on a carbidopa/levodopa regimen.

Acorda Therapeutics’ therapy is expected to be available by prescription in the first quarter of 2019. It will be distributed through a network of specialty pharmacies in the U.S.

“Today’s approval of INBRIJA marks a major milestone for both Acorda and the Parkinson’s community, for whom we are gratified to have developed this much needed therapy,” Ron Cohen, MD, Acorda’s president and CEO, said in a press release. Cohen noted the more than “two decades of research and development” needed for this approval, as well as the “enormous perseverance and ingenuity” by Acorda’s team.

Inbrija is a self-administered, orally inhaled levodopa treatment for off periods, which are characterized by the re-emergence of Parkinson’s motor symptoms due to low levels of dopamine between doses of standard treatment. These off episodes are typically more common as the disease progresses.

The Michael J. Fox Foundation helped to fund the early development of Acorda’s medication, a decision based on the impact off periods have on patients’ lives, according to Todd Sherer, PhD, the foundation’s CEO.

“We knew we had to help address this unmet need, and this approval is a significant step forward for the community as it provides a new option to manage these gaps in symptom control,” he said.

Inbrija uses Acorda’s ARCUS technology, a system designed to deliver medication to the lungs through inhalation. ARCUS transforms molecules into a light, porous, dry powder, enabling the delivery of much higher doses of medication.

The FDA’s decision was based on a clinical program that included approximately 900 Parkinson’s patients. The pivotal Phase 3 SPAN-PD trial (NCT02240030) evaluated the efficacy and safety of 84 mg and 60 mg of Inbrija in 351 participants with mild to moderate Parkinson’s who were experiencing off periods.

Results of the double-blind study showed a statistically significant improvement in motor function at the final 12-week visit, seen by a reduction in the Unified Parkinson’s Disease Rating Scale Part III (UPDRS-III) score with Inbrija’s higher dose, compared with placebo, at 30 minutes post-dose. Inbrija’s effects were seen as early as 10 minutes after treatment.

The most common adverse reactions with Inbrija were cough, upper respiratory tract infection, nausea, and discolored sputum, which may indicate a bacterial infection.

Treatment with Inbrija was also analyzed in a one-year, randomized, open-label Phase 3 trial with 398 participants (NCT02352363). Results showed a similar average reduction in forced expiratory volume in one second — a measure of pulmonary function — in the Inbrija (84 mg) and observational groups.

Inbrija also eased Parkinson’s symptoms at all time points, as measured with the UPDRS-III scale, enabled symptom control within 60 minutes of the dose and reduction of total daily off times, and led to improved Patient Global Impression of Change scores in 75% of patients, which reflects the patients’ assessment of treatment effectiveness.

“In the clinical study program, Inbrija established its safety profile and demonstrated clinically meaningful improvements in motor function,” said Robert A. Hauser, MD, a professor of neurology and director of the Parkinson’s Disease and Movement Disorders Center at the University of South Florida. “Inbrija helps address a significant unmet need for people with Parkinson’s, and we look forward to adding this new treatment option to our armamentarium.”

Inbrija is not to be used by patients currently on or treated with a nonselective monoamine oxidase inhibitor, such as the antidepressants and anxiolytics phenelzine or tranylcypromine, within the last two weeks.

The company is currently seeking EU approval for Inbrija.

Burkhard Blank, MD, Acorda’s chief medical officer, said he was “delighted” with Inbrija’s approval and its upcoming availability for on-demand use, based on each patient’s needs.

“We thank the FDA for a constructive dialogue throughout the development program and their partnership during the review cycle. We especially thank all those who volunteered for the Inbrija clinical trials, without whose commitment new medications could not be developed,” he said.

He further noted the important role played by “people living with Parkinson’s, their care partners, researchers, clinicians and advocacy groups,” to achieve FDA approval.

A webcast of a recent conference call hosted by Acorda is available here.

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New Art Initiative Aims to Improve Understanding and Discussion of Parkinson’s Off Periods

art initiative, off periods

A new initiative by Acorda Therapeutics uses art to help people with Parkinson’s disease recognize and communicate about their off-period experiences.

The initiative, called Framing OFF Through Art, builds on Acorda’s Live Well. Do Tell program, launched earlier this year.

Framing OFF Through Art includes artwork inspired by the experiences of patients with Parkinson’s and their caregivers. The artists who created the pieces also have personal connections to the disease. Each artist partnered with two patients and their caregivers. The art aims to educate and encourage others with Parkinson’s and their care partners to identify off-period symptoms and discuss them with their healthcare professionals.

“Art is a powerful way to engage a community, and in Framing OFF Through Art, our goal is to create an emotional connection that results in better dialogues about Parkinson’s symptoms,” Ron Cohen, MD, Acorda’s president and CEO, said in a press release.

The artwork debuted on Oct. 23 at an event in New York, where the artists, patients, and their caregivers were guests. The first piece was created by Julie B., whose mom is living with the disease, and is available on the Live Well. Do Tell website. More art and personal stories will be revealed each month.

“I know that some of these symptoms are really difficult to put into words. A visual representation can really communicate what you are going through,” Julie B. said in a video interview. “One of the big takeaways from this initiative is the idea of an open and honest conversation.”

Off periods are a common complication in Parkinson’s patients, characterized by the return of motor and non-motor symptoms — such as anxiety and sadness — when levodopa’s effects wear off. The need to better understand off periods, as well as how to talk with others about them, had been originally highlighted in the Live Well. Do Tell statement of need.

This report was the first output of the campaign, and includes six actions for the Parkinson’s community: tailor resources at diagnosis; broaden the Parkinson’s community’s ability to identify off periods; educate about motor fluctuations and how they do not necessarily mean disease progression; identify opportunities for caregivers to discuss their experiences with healthcare professionals; enhance the patient-clinician dialogue; and improve clinical practice via insights from movement disorder specialists and a new tool to measure off periods.

The report was based on insights from the campaign’s steering committee meeting that included Parkinson’s community leaders. Others may join the conversation by signing up for initiative updates and news.

“Off periods can be frustrating and challenging, as symptoms are varied and often difficult for patients to communicate effectively to their care providers,” said Matthew Stern, MD, director emeritus of the Parkinson’s Disease and Movement Disorders Center at Penn Medicine.

“By helping people with Parkinson’s understand how to verbalize what they are experiencing, we, as their healthcare providers, can better understand their needs and help them achieve a better sense of well-being,” added Stern, who is the chair of the Live Well. Do Tell steering committee.

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#AAN2018- Inbrija Reduces Parkinson’s Off Periods, Phase 3 Trial Shows

Phase 3 Inbrija trial

Inbrija reduces Parkinson’s symptoms when standard treatments wear off, and decreases the length of these off periods, a Phase 3 clinical trial shows.

The therapy’s developer, Acorda Therapeutics, will present the results at the American Academy of Neurology annual meeting in Los Angeles, April 21-27. Parkinson’s News Today will be covering the conference.

Acorda’s presentation will be at 4:54 p.m. Pacific time on Tuesday, April 24. The title will be “Long-term Efficacy of Inhaled Levodopa in Parkinson’s Disease Subjects With Motor Fluctuations: a Phase 3 Open-Label Randomized Study.”

Inbrija (CVT-301) is a self-administered, inhaled version of levodopa intended to reduce the time when standard levodopa treatment wears off — periods known as off times.

Acorda conducted the Phase 3 trial (NCT02352363) to evaluate the safety and effectiveness of an 84-mg dose of Inbrija over 12 months in 408 Parkinson’s patients with movement problems.

The Inbrija group consisted of 278 patients. The other 130 were assigned to standard care. Only 204 of the patients who received Inbrija were able to complete the trial.

At the beginning of the study, the Inbrija group had a mean age of 63.6 years, had had Parkinson’s for nine years, were averaging 3.6 off periods a day, and were experiencing total off times of 5.6 hours per day. Patients took an average of 2.3 doses of Inbrija a day.

One of the measures that researchers used to measure Inbrija’s effectiveness was improvements in patients’ UPDRS-III scores, which assess both movement and non-movement symptoms, 10, 20, 30, and 60 minutes after dosing. Another measure was the percentage of patients able to regain control of their symptoms within 60 minutes of treatment.

Still another measure was reductions in patients’ off times. And a fourth was better scores on a scale known as PGIC, which shows whether a patient believes a treatment is effective.

A key finding was improvements in Parkinson’s symptoms at all time points between week 4 and 52 on the UPDRS-III scale.

Another finding was that patients were able to regain control of their symptoms within 60 minutes.

In addition, patients were able to reduced their total daily off times by between 1.32 and 1.42 hours. And 75 percent of patients showed improvements in PGIC scores.

Overall, improvements in UPDRS-III scores, daily off times and PGIC scores “support the efficacy of up to 52 weeks of treatment with CVT-301 (Inbrija) 84 mg in the treatment of off period symptoms,” the researchers wrote.

The results prompted Acorda to seek European Union approval of Inbrija as a treatment for off periods in Parkinson’s.

In addition to data from this Phase 3 trial, Acorda’s application to the EU included results of the Phase 3 SPAN-PD trial (NCT02240030) in 351 participants and the Phase 3 CVT-301-004E trial (NCT02242487) in 325 participants.

The U.S. Food and Drug Administration accepted Acorda’s New Drug Application for Inbrija in February 2018. It is expected to decide whether to approve it by October 5.

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Source: Parkinson's News Today

Acorda Campaign Aims to Help Parkinson’s Patients Explain Their Challenges

Steve DeWitte

An initiative called Live Well. Do Tell is trying to help Parkinson’s patients do a better job of letting others know about the manifestations of their disease, particularly the return of movement problems during periods when standard treatments wear off.
In addition to these off periods, many people are unaware of the non-movement symptoms of Parkinson’s, including depression or anxiety.
One feature of the Acorda Therapeutics initiative is a downloadable action guide designed to help patients and caregivers do better at identifying and communicating symptoms.  The guide grew out of a meeting of patients, healthcare professionals and others on Sept. 17, 2017. The main thrust of the gathering was finding ways of both addressing the disease’s  challenges and letting others know about them.
Suggestions included broadening people’s understanding of off periods, helping caregivers  do a better job of describing the symptoms they are seeing to healthcare professionals, and coming up with a better way of measuring off periods.

“This disease can be a hard disease, but there’s a whole lot of hope right now, too, because of a growing understanding of how it manifests,” said Sarah Jones, chief executive of the Parkinson & Movement Disorder Alliance, and a member of the initiative’s steering committee. “This group balances truth-telling with power. Information is power, along with knowing what to do with it.”

Others are invited to join the conversation by signing up for initiative updates and news.

Parkinson’s is a progressive neurodegenerative disorder that predominately affects dopamine-producing nerve cells in an area of the brain called substantia nigra. Experts estimate that it affects a million people in the U.S. and 10 million worldwide.

Because of the variety of symptoms, patients usually see a number of specialists over the course of their disease, including neurologists and movement-disorder experts.

Matthew Stern
Dr. Matthew Stern, a neurologist, was chair of the Live Well. Do Tell steering committee. (Photos courtesy of Acorda Therapeutics)

Too often, physicians focus on visible symptoms such as tremors, slow or jerky movements, limb rigidity, and walking and balance problems, said Matthew Stern, a professor emeritus of neurology at the University of Pennsylvania’s Perelman School of Medicine. Meanwhile, doctors often focus on depression and constipation in  judging quality of life. Stern was chair of the Live Well. Do Tell steering committee.

“It’s no longer about just walking into an exam room. It’s about you taking control of your own health care,” said Stern, former director of the Penn Parkinson’s Disease and Movement Disorders Center. “But a byproduct will be increased doctor awareness as well. There’s a disconnect between what a patient is saying and what the doctor is hearing.”

Although off times can cause movement problems and complications such as difficulty swallowing, they also can lead to bouts of anxiety and sadness — less-evident symptoms that often go undiagnosed. Up to 80 percent of Parkinson’s patients experience off times daily, Jones said.

Because movement and other difficulties return during off times, patients can find it hard or embarrassing to discuss these periods. Often, they aren’t sure how to explain what they feel about them.

“The complications of off times really lend themselves to misunderstandings, and can also really overwhelm people dealing with the disease,” Jones said. “This organization raises a voice in terms of understanding what off time is, and the fact that it varies.”

These periods can also leave patients with feelings of inadequacy or failure. “They feel like they aren’t managing as well as they want to,” Jones said. “It can be tied to stress or not sleeping well. So, normalizing it is very helpful. If there’s no way to talk about it, it can be seen as a criticism or can create challenges, as opposed to being a part of living.”

Options for managing off times include diet and medication adjustments and, for some, surgical approaches such as implanting deep brain stimulation devices.

Acorda has asked the U.S. Food and Drug Administration to approve a treatment it developed for off times. Inbrija is an inhaled powder formulation of levodopa designed to act quickly when the effects of oral levodopa and carbidopa wear off.

The FDA is expected to decide whether to approve inbrija by Oct. 5. Acorda’s application for approval was based partly on the benefits seen in a Phase 3 clinical trial (NCT02240030).

“Off periods greatly disrupt the lives of people living with Parkinson’s, and there is significant need for new treatments in this community,” Dr. Burkhard Blank, Acorda’s chief medical officer, said in a press release.

Most Parkinson’s patients are diagnosed between the ages of 55 and 60 while still employed, leading to panic and fear. That’s when doctors need to reassure them, Stern said.

“Patients think they’ll be in a wheelchair in five years,” he said. “So, step one is educating a diagnosis. When I was in clinical practice, I spent a lot of time undoing what they’re told and what they’ve learned on the internet.”

Steve DeWitte of Connecticut had no idea of “how to react” when diagnosed with Parkinson’s in 2005.

Steve DeWitte was 48 and a Special Olympics regional director when he received his diagnosis. Two years earlier, his symptoms had begun with a shaky left pinky finger. The tremors spread to more fingers and then his entire left arm. He eventually also had bouts of fatigue, sleeping difficulties and constipation.

“I didn’t know what Parkinson’s was, so I didn’t know how to react or not react,” said DeWitte, a resident of New Preston, Connecticut, who founded Connecticut Advocates for Parkinson’s. “Then I said, ‘OK, I’ll accept it.’ After that, I did my own research and joined support groups to find out what steps I had to take to live a quality life.”

Now 61, DeWitte said how he feels about his situation can change hourly. Overall, he said, he is able to manage his disease, including off times, with medicine, diet and exercise. He’s been involved with the Live Well. Do Tell effort from the beginning.

“It’s a great program for individuals as they start examining how to live with Parkinson’s, and how doctors can better communicate with you,” said DeWitte, who is married and has an adult child. “I give my interpretation of how we’re living with this condition, how we talk to physicians and how they listen, and how they can be more clear with us.”

He thinks the initiative has helped create a more honest dialogue between patients and physicians. “Patients feel more comfortable coming out with what they experience,” he said. “We’ve had wonderful sessions leading us through how to prepare for our visits, and getting helpful hints about how to make each visit more impactful. It makes it easier on the physicians, too.”

Insights into these sessions are available for downloading.

Jones said the bottom line with Live Well. Do Tell is that it challenges everyone in the Parkinson’s community to do a better job at explaining the disease and its symptoms, and it challenges patients to advocate for themselves.

“It feels like this is the first time that a large organization has pulled together a really diverse multidisciplinary team of people to have a conversation about more than motor symptoms,” she said.

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Source: Parkinson's News Today

Acorda Asks European Union to Approve Inbrija for Parkinson’s Off Periods

Inbrija approval request

Acorda Therapeutics has asked the European Medicines Agency to approve Inbrija (CVT-301) to reduce the periods when the standard Parkinson’s treatment carbidopa/levodopa is not working.

Inbrija is a self-administered, inhaled levodopa therapy. Acorda developed it to reduce the time when standard levodopa treatment wears off — periods known as off times.

Both movement and non-movement symptoms return during off times. About half of  patients taking standard levodopa have off periods, which become more frequent and severe during the course of the disease.

Inbrija was designed to deliver a precise dose of a dry powder form of levodopa to patients’ brains. The powder form bypasses the digestive system, preventing delays in the medication kicking in.

Acorda filed a marketing authorization application asking the European Union to approve the therapy. The application included results from its 12-week Phase 3 SPAN-PD clinical trial (NCT02240030). The study assessed the safety and effectiveness of 84-mg and 60-mg doses of Inbrija’s administered up to five times a day in 351 Parkinson’s patients experiencing off periods.

Inbrija improved patients’ movement in comparison with a placebo, results showed.

In line with a previous Phase 2b trial, researchers found no lung safety concerns. The most common adverse events were cough, upper respiratory tract infection, and throat irritation.

Acorda presented the SPAN-PD results at the International Congress of Parkinson’s Disease and Movement Disorders in Vancouver, Canada, in June 2017.

The application included the results of two long-term Phase 3 safety trials as well. The CVT-301-005 trial (NCT02352363) covered 408 patients, and the CVT-301-004E study (NCT02242487) 325 participants.

Researchers found no changes in the treated patients’ lung function, compared with standard levodopa treatment. Taken together, the findings indicated that Inbrija was safe as an off-period treatment, Acorda said.

The U.S. Food and Drug Administration accepted Acorda’s New Drug Application for Inbrija in February 2018. It expects to decide by October 5 whether to approve it.

U.S. regulators refused to accept Acord’s initial application due to concerns over the manufacturing of Inbrija. The company addressed the questions in a revised application.

Acorda’s European application covers all European Union countries, as well as Norway, Liechtenstein, and Iceland.

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Source: Parkinson's News Today

FDA Accepts New Drug Application for Acorda’s Parkinson’s Therapy Inbrija

FDA review for Inbrija

The U.S. Food and Drug Administration has accepted Acorda Therapeutics’ New Drug Application for Inbrija (CVT-301) as a potential treatment for Parkinson’s disease.

Accepting the application means the agency is ready to start its regulatory review of the therapy. It expects to make a decision by Oct. 5, 2018.

Inbrija is an inhaled powder formulation of levodopa for the times when the punch of Parkinson’s patients’ oral levodopa and carbidopa regimen wears off. Doctors refer to such times as off periods.

Although levodopa is the most effective oral Parkinson’s therapy, many patients experience movement difficulties during off periods, which become more common as the disease progresses.

“Off periods greatly disrupt the lives of people living with Parkinson’s, and there is a significant need for new treatments in this community,” Dr. Burkhard Blank, Acorda’s chief medical officers, said in a press release.

The New Drug Application included results of the 12-week Phase 3 SPAN-PD clinical trial (NCT02240030), which covered 351 patients. It showed that a high dose of Inbrija administered up to five times a day improved patients’ movement during off periods, compared with a placebo. The results were in line with those of a Phase 2b trial.

FDA officials initially refused to accept the application for Inbrija — not because of safety or effectiveness concerns, but because of questions about its manufacturing process. Acorda addressed the questions in its resubmitted application.

“People with Parkinson’s and physicians need more options to manage this disease,” said Dr. Todd Sherer, the CEO of The Michael J. Fox Foundation. “Inhaled delivery of levodopa could help the many people living with Parkinson’s facing the complication of off periods as their disease progresses.”

The foundation funded some of the work of the therapy’s original developer, Civitas. Acorda acquired Civitas later.

Acorda uses its ARCUS delivery system to get Inbrija powder into patients’ lungs. From there it travels to the brain.

Oral and nasal-passage-delivered medications are administered through the digestive tract, getting to the brain slower.

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Source: Parkinson's News Today