New Parkinson’s “Off” Therapy Receives FDA Approval

New Parkinson’s “Off” Therapy Receives FDA Approval

On May 21, 2020, the U.S. Food and Drug Administration (FDA) approved an under-the-tongue dissolvable medication to quickly reverse “off” time, when Parkinson’s disease (PD) symptoms return between medication doses. Sunovion Pharmaceuticals Inc.’s Kynmobi (apomorphine) mimics dopamine, the brain chemical responsible for normal movement, which decreases in Parkinson’s. This approval provides a new treatment option for people with Parkinson’s and marks a significant milestone for The Michael J. Fox Foundation (MJFF). With the support of early investments from MJFF, Kynmobi is the second Foundation-funded PD drug to earn FDA approval.

“The remarkable momentum in Parkinson’s research continues, and MJFF is proud to contribute to this success,” said MJFF CEO Todd Sherer, PhD. “This approval brings an important new treatment option for people with Parkinson’s who experience ‘off.’ We know from our research and discussions with the Parkinson’s community that ‘off’ time can significantly disrupt daily life, which is why we funded early clinical development of Kynmobi.”

Kynmobi — a thin-film formulation of apomorphine placed under the tongue — is meant to be used as needed for “off” time, up to five times per day, in addition to other daily Parkinson’s medications. (This is similar to asthma therapy, in which a person might take a daily treatment to keep breathing under control and, at the same time, use a rescue inhaler if breathing temporarily worsens.) For those who experience “off” time, it can come on in different ways and with different symptoms. “Off” time can happen suddenly or unexpectedly; gradually, as a wearing off before the next dose is scheduled; or in the morning, before the first dose is taken. For many people, “off” involves movement symptoms, such as tremor, slowness or stiffness. For others, it includes non-movement symptoms, such as anxiety or mental fogginess.

MJFF funded more than $1.4 million to support Phase I and II trials on Kynmobi, thereby “de-risking” the therapy and enabling Phase III randomized, controlled clinical trials that demonstrated safety and efficacy. In the final step of clinical testing, more than 100 people with Parkinson’s evaluated the drug, finding that it significantly decreased movement symptoms within 30 minutes.

Potential benefits may include quick treatment of “off” time (which might offer a bridge until the next dose of scheduled medication kicks in); the security of knowing a “rescue” is there if needed, which might expand social or exercise opportunities; and others. Possible side effects could include tongue soreness or swelling, nausea, sleepiness or dizziness.

Kynmobi is expected to be available in the U.S. by prescription in September. (Learn more about Kynmobi.) With the approval of this drug, people with “off” time have another option to use as needed. Others include Ongentys, a COMT inhibitor approved in April 2020, Apokyn, an apomorphine injection, and Inbrija, a levodopa inhaler, which was the first therapy funded by MJFFto gain FDA approval. Like all medications, each has pros and cons and reasons it may or may not be suitable for each individual.

Read our press release on Kynmobi.

Parkinson’s UK Research Round Up – May 2020

Parkinson’s UK Research Round Up – May 2020

Parkinson’s research and COVID-19

Parkinson’s won’t stop during this pandemic. Neither can the search for better treatments and a cure. We take a look at how research is moving forward during lockdown.

From finding out more about research to getting involved, there’s something for everyone.

  • Results from a phase 2 clinical trial of a vaccine for Parkinson’s. We’re hearing a lot about vaccines in the news at the moment. And we’re learning that they take time to develop and test. But it isn’t just COVID-19 where a vaccine may be key to saving lives.
  • Researchers identify a missing link in genetic Parkinson’s. The results of this Parkinson’s UK-funded study may help explain why some brain cells are more susceptible to Parkinson’s than others. The findings could open the door to new and better treatments.
  • Have you completed Parkinson’s UK’s coronavirus survey yet? We’re working with researchers at Lancaster University to understand more about how people with Parkinson’s and their loved ones are affected by the coronavirus.

You can register to receive our research emails by visiting here and clicking on “Join the Network.”

By clicking on the link below you will be able to access a PDF file.

May 2020 Research Roundup

 

 

 

More online exercise opportunities for all abilities

More online exercise opportunities for all abilities

You are definitely not allowed to rest in lock-down.

Below are details of more exercise classes organised by Parkinson’s UK – there are classes for all levels so check them out.

Neuro-physios and Parkinson’s UK have teamed up to create online exercise classes to inspire home exercise at this crazy time.

A range of videos will be uploaded to a playlist on the Parkinson’s UK YouTube page. The exercise classes target all abilities so make sure you scroll until you find the class that suits you!

In addition there are videos on the Parkinson’s UK Facebook Page – see below for links

Bev Ball, neuro-physio with over a decade of expertise in Parkinson’s exercise, will be running a class for those with mild to moderate symptoms of Parkinson’s incorporating a Pilates style warm-up, moderate to vigorous aerobics focusing on weight transfer and stepping and a warm down including Tai Chi breathing techniques. Details here.

Sally Tawhai and Maria Lewis founders of Reach Your Peak online exercise will be taking a chair-based class, ideal for people who have difficulty with their balance or for whatever other reason, feel safer exercising seated. Although it is a seated class it will still contain all the Reach Your Peak principles, working at a moderate to vigorous intensity to drive the neuro-plastic changes that promote symptom control. Details here.

Karen Hodgson, Director and Clinical Lead for Neurology at the Hallamshire Physiotherapy Clinic in Sheffield will be offering a class of higher intensity exercises designed to get you out of breath and working hard. It will exercise your body as a whole. You will need to have good balance and be fit enough to exercise in standing for 30 minutes’. Details here.

 

Lock-down distractions

Lock-down distractions

Whilst we are in these weird times, how about a couple of useful distractions which may help us to connect with others and at the same time support Parkinson’s UK with its Emergency Appeal? 

Three ideas …. 

  1. Why not organise a virtual quiz night?
  2. Get involved in the 2.6 challenge
  3. Online Scrabble with friends.

Some details are provided below …… 

Hosting a virtual quiz night

 

Fancy yourself a quizzical quiz master? Organise a virtual quiz to help us continue answering critical questions on our helpline to support people with Parkinson’s. It’s a great way to connect with family and friends while raising funds.

Parkinson’s UK has all the questions, answers and guides to hosting your virtual quiz night – find the details here. 

Alternatively, how about organising a 2.6 Challenge

 

Change lives in lockdown. Join the 2.6 Challenge and become a stay at home hero for people with Parkinson’s. All the details are here.

Your challenge can be anything you want – just link it to the number 2.6 or 26. Maybe you’ll run 2.6 miles round your garden? Or hold an online dance party with 26 friends? Whatever you choose, you’ll be a stay-at-home hero for people with Parkinson’s. 

Once you’ve dreamt up your challenge, you can set up your very own fundraising page on JustGiving or Virgin Money Giving. 

You’ll be able to share your challenge with others, provide updates, and collect donations. Did you know that £26 could help local advisers make welfare calls, reaching out to people who are isolated and vulnerable. £260 could help provide critical support to two families throughout the Coronavirus crisis.

And finally online Scrabble ….

There is a completely free online Scrabble app available from Lexolous.

Each person just registers to create an account, you join The Lounge, set up a new game and away you go! Details are here.

 

April 2020 Research Roundup Newsletter

April 2020 Research Roundup Newsletter

The Parkinson’s UK Research Support Network (RSN) connects you to Parkinson’s research.

From finding out more about research to getting involved, there’s something for everyone.

  • Beyond Dopamine
  • Technology that turns down Parkinson’s symptoms
  • AMBLED trials
  • Taking part

You can register to receive our research emails by visiting www.parkinsons.org.uk/research/get-involved-research and clicking on “Join the Network.”

Please find attached April’s Research Roundup newsletter which includes links to two studies that can be completed from home, which may be of particular interest.

By clicking on the link below you will be able to access a PDF file.

April 2020 Research Roundup