Sensidose has developed a treatment concept for individualized and fine-tuned treatment of Parkinson's disease. The company's microtablets, Flexible life, contains small doses of levodopa that compensates for the lack of dopamine.
Using the company's dose dispenser MyFID The patient can receive a precise dose at specific times, allowing treatment to be tailored to each patient's needs.
On-off symptoms common in Parkinson's patients
Levodopa has been the standard treatment for Parkinson's disease for decades. The treatment effectively relieves symptoms, but can also cause a so-called on-off phenomenon, where patients' symptoms fluctuate rapidly. Immobility and rigidity (off-period) can quickly transition to hypermobility and involuntary muscle movements (on-period).
These variations in motor ability are uncommon during the first few years, which are referred to as the “honeymoon period of Parkinson's disease” in Sten-Magnus Aquilonius Book Along the dream path – a neurology professor's experiences and reflections (2021).
Sten-Magnus Aquilonius research
Understanding the background to symptom fluctuations, and what to do to counteract them, has been a major focus of Aquilonius' research at Uppsala University. He and his colleagues saw that variations in the concentration of levodopa in the blood led to variations in the dopamine produced in the brain, which in turn led to rapid changes in movement patterns and the so-called on-off symptoms. The researchers realized that these problems could be overcome if they managed to create a consistent concentration of the drug in the blood and adapt the dose to the individual patient's needs.
This is how the idea for the Sensidose treatment principle was born.
The insights gave rise to the Uppsala-based pharmaceutical company Neopharma and the development of the drugduodopa, a gel formulation of levodopa for continuous delivery to the small intestine using a pump. Neopharma launched Duodopa in 2004 and was subsequently acquired by Abbott/Abbvie.
Duodopa allows seriously ill Parkinson's patients to have a steady and adjustable level of levodopa in their blood, but can also lead to certain side effects such as infections and pain. Professors Sten-Magnus Aquilonius and Christer Nystrom realized that this treatment principle could be implemented in a simpler, less invasive way through frequent dosing of oral microtablets and a dosing machine – the idea for Sensidose was born!
Interview with Sten-Magnus Aquilonius
The idea led Sten-Magnus and Christer to found Sensidose in 1998. Today, Sten-Magnus is a board member of the company and professor emeritus at the Department of Neuroscience at Uppsala University. BioStock contacted Sten-Magnus to hear his thoughts on Sensidose's journey.
Could you first tell us a little bit about yourself and your professional years?
– You could say that I was involved in “the golden age of Swedish neuroscience”, which is a period where significant progress was made in Swedish neuroscience and was at the forefront of Parkinson's research.
– I began my career in basic research and experimental neuroscience, before moving to the clinic. I have conducted most of my research at Uppsala University.
– Also worth mentioning is that I have collaborated with many prominent people in the field, including Arvid Carlsson, who received the Nobel Prize in Medicine in 2000 for his research on brain neurotransmitters.
»You could say that I was part of “the golden age of Swedish neuroscience”«
In what ways are symptom fluctuations and on/off periods troublesome for patients with Parkinson's disease?
– In principle, all Parkinson's patients treated with levodopa suffer from symptom fluctuations. Some experience problems after just three years, and the vast majority are affected after eight years of illness.
– The on-off periods and the motor complications significantly affect everyday life. The so-called off period can be very troublesome as patients become stiff and may not be able to walk or move normally. Here the patient can also feel depressive, apathetic and anxious. The on symptoms can instead have certain social consequences as the involuntary movements can cause people around them to react.
– In our research, we were able to create an understanding of the on-off symptoms and levodopa uptake in the brain using PET scanning and carbon-11-labeled levodopa.
You were first involved in the development of Duodopa at Neopharma and then Flexilev at Sensidose. How did you come to the conclusion that there is a need for both of these drugs?
– The basic idea behind both Neopharma and Sensidose is so-called continuous dopamine stimulation, which is today an established treatment principle for reducing symptom fluctuations during treatment with levodopa. We had the ideas for both treatment strategies from the beginning, but for financial reasons, among other things, we could only start developing one of them.
»The basic idea of both Neopharma and Sensidose is so-called continuous dopamine stimulation, which is today an established treatment principle«
What are the advantages of Flexilev compared to Duodopa?
– In pump-controlled treatment with duodopa, a port is needed through the abdominal wall, which can lead to certain complications and limitations for the patient. With Sensidose tablets, no invasive method is required, which makes the treatment much more comfortable for the patient. Absorption still occurs in the small intestine and the dose can be finely titrated very well because Flexilev is dosed several times a day, usually six times.
What scientific evidence is there that supports Sensidose's treatment principle?
– There is a list on Sensidose website with references to a number of different publications that support the company's treatment principle.
– Then there remains the possibility of proving that Flexilev can possibly even prevent symptom fluctuations from occurring if you start treatment very early. There is some support for this, but we have not yet been able to do a larger study on this. Currently, Flexilev is used when fluctuations have already occurred and you start to consider invasive treatment, i.e. pump-controlled treatment with duodopa or deep brain stimulation (DBS). With Flexilev, you can postpone the start of these invasive treatments or even avoid them.
– We currently do not conduct any research activities in the company – full focus is on marketing and product development. An important task is to train nurses in the area to make them realize the benefits of Flexilev.
What role do you have in Sensidose today?
– I am on the board where my task, among other things, is to monitor databases and progress in the Parkinson's field. My role in Sensidose has always been to be responsible for the clinical insight and provide advice on crucial decisions, as well as to spread knowledge about the treatment principle by giving lectures at congresses, etc.
– I would also like to take this opportunity to say that Sensidose has a very competent board and management. We have also recently started an advisory board where I am one of those responsible for contact with these key people.
– We are a small company that is still in the early stages of international expansion. To strengthen the organization ahead of the expansion, we have recruited Philip Slätis to the role of Vice President and Åsa Kornfeld to the board.
Finally, a broader launch of Flexilev is imminent, what future do you see for the Sensidose treatment concept?
– We are now focusing on entering more markets with Flexilev. The drug is approved in many European countries, but has so far only been launched in Sweden, Norway and Denmark.
»We are now focusing on entering more markets with Flexilev. The drug is approved in many European countries«
– The market introduction is greatly influenced by the pricing you get in the country. All countries have an authority that controls pricing. In the Scandinavian countries we got very good pricing. We are now negotiating pricing in two more countries – Finland and Poland.
– For some time, expansion and sales have been affected by production problems due to the global semiconductor shortage, but now this is starting to ease, so we expect a positive development in the fall. Even during the Covid pandemic, we had increased sales and we expect a similar trend in the future!
