In the interest of patients and their safety, development of drugs and new therapeutic are the results of long and complicated processes. Next to intensive research, each approach has to undergo several testing phases before it is ready for the market. This generally takes several years.

With our N2B-patch project we are still in the research phase and aim to achieve a proof-of-concept and preclinical validation by the year 2020. Once validated, the approach shall be tested first in the clinic and then on MS patients. After a successful clinical validation and admission, production and market launch can start.

We are convinced that good research results need to include the patient’s perspective and respond to their needs. That is why the voice of MS patients’ represented by the European MS Platform is included from a very early stage on in this N2B-patch project.

Please feel free to get in touch with us! Our team includes the largest association of MS patients in Europe (EMSP). EMSP is the umbrella organisation for 40 MS societies from 35 European countries, representing their interests at the European level.



This section covers the most frequently asked questions (FAQ’s) regarding the N2B-Patch project as well as provide more information for patients. Are you still not finding the answer you were looking for? Please do not hesitate to contact us.


What is the N2B-Patch project?

The N2B-Patch is a project funded by the European Union, which brings together universities, research institutes, SMEs, industry and patients organisations to explore the possibility to have treatments (in MS) that bypass the Blood Brain Barrier.

A full list of all the organisations involved can be found here.


Why would you want to bypass the blood brain barrier?

Currently, there is no efficient method to permanently bypass the blood-brain barrier, it is for this reason that this project is so innovative and important.

Bypassing the blood brain barrier could lead to a more effective way of treating MS – and potentially also be a less invasive treatment for patients. Developing a ‘nose to brain’ delivery system, thus bypassing the blood-brain barrier, could avoid the need for injections and oral medicine to treat MS.


What are you trying to deliver via this project?

The N2B-Patch aims to deliver three concrete outputs:

  • The first is the drug particle, the treatment for MS
  • The second is the gel, which will serve as a less invasive drug-carrier
  • The third is the device which will apply the drug and gel

The combination of these three outputs will hopefully result in a treatment bypassing the blood brain barrier, thus enabling a more efficient treatment for MS.


When will these outputs be of use for patients?

N2B-patch is numerous years away from regulatory approval and it is not anticipated that a regulatory submission would be made within the next 5 years.

This is because N2B-patch must go through a series of very large and expensive clinical trial phases to test whether it is safe and whether it works. Patient recruitment and retention will be quite challenging due to varying levels of disease progression and measuring clinical endpoints. MS patients and patient groups involvement will be absolutely essential to bringing this innovative drug delivery system to market.


Would this technology be applicable for other diseases than MS?

Although this project focusses on MS, we do envision that this technology will support the treatment of other demyelinating disorders and other central nervous system indications, e.g. stroke, neurodegenerative diseases or tumours.


A large number of people with MS administer their drugs by injection and through infusion. Those methods can be uncomfortable and quite painful. Also oral medication can be cumbersome. What alternative N2Bpatch can offer?

Currently, nasal delivery is predominantly limited to nasal sprays or inhalation. The N2B-patch is a novel administration technique and no clinical experiences are available at the moment. According to ear-nose-throat specialist, no pain or effect on smelling and tasting are expected. Nevertheless, a final statement can not be made before more studies will be performed in the field.


People with MS want a MS cure or improved treatments. Does N2B-patch seek this goal?

N2B-patch seeks to achieve a more efficient way to deliver existing treatments to MS patients in a way that more drug reaches the affected regions of the central nervous system (CNS, brain and spinal cord) but the objective is not finding a cure for MS. However, using the new technique as a platform for drug delivery directly to the CNS may facilitate development of new drugs in future. Direct effects in the CNS could potentially increase therapeutic efficacy of different drugs.


Many people with MS take their medications on a daily basis. Would N2B-patch project results offer administration of drugs on a less frequent basis?

We are seeking a way to minimise the frequency of drug administration and to reduce the amount of medicine required for each dose. We are aiming that the patch will deliver drug at least for one week or longer.  This would help improve the quality of life of people with MS.


Will the administration of drugs via the N2B-patch device require the intervention of healthcare professional or can the patient be able to manage the patch by themselves? Will it result in less visits to the hospital?

The answer is yet to be concluded but it is most likely that the patient will still require the drug to be administered by a trained healthcare professional. The first generation of N2B-patch shall be administered in specialized clinics or in the praxis of ear-nose-throat doctors that received a special training. Later generations of the patch might be suitable for self-administration.


Do you believe this new drug delivery system will support better adherence of people with MS to their treatment?

It is a regulatory requirement to justify and prove the quality, safety and efficacy of the drug whilst at the same time demonstrating the clinical benefit, state of the art and performance of the device. The risk ratio/benefit has to be justified and also patient adherence is a fundamental aspect of N2B-patch development. This summary of MS patient survey forms one small part of the data collection which is necessary to put the patient first and to understand patient expectations.


What kind of side effects might be expected with the use of the N2B-patch drug delivery system?

N2B-patch is currently in a research phase and the aim is to achieve proof of concept.  The involved scientists and technical experts are working intensively to generate data which is intended to demonstrate that this design concept is feasible and to prove the future potential for this technology. No human clinical trials are planned during the scope of this project so side effects will not be known. 


How scientists came up with this project idea and what are their motivations for working on such a drug delivery system?

The blood-brain barrier (BBB) is a physical barrier which separates the CNS from general circulation. However, this barrier also limits direct access of different drugs like monoclonal antibodies or cytokines to the CNS. This fact limits the therapy of highly efficient drugs severely.  The N2B-patch research project represents a great challenge for the scientists and technical experts as they aim to overcome the BBB by bypassing drugs through nose directly to the CNS.


What are the latest developments in MS research that we should be aware of?

Although modest in effect, new therapies for chronic progressive disease (primary and secondary progressive disease; PPMS and SPMS) are an important milestone in drug development. Also approaches to try to tailor the benefit risk profile of the drugs to individual patients are moving forward. This is particularly important since we have recently also seen unanticipated adverse drug reactions of already established drugs.


Why are patients and EMSP involved in the project?

It is of crucial importance to consult the patient community on their needs and expectations to ensure that the final product meets those. MS is a life-long disease where treatments and care are crucial to help maintain a productive and fulfilling life. However, painful and uncomfortable drug delivery impact on the overall quality of life of MSers reducing their productivity. By working on this device together with the MS community and ensuring that their feedback is integrated along the way, the chances that it fits the expectations will be higher.


Why is the EU funding this project?

MS is the most important CNS disease affecting young and middle aged Europeans (about 2 to 3 times more common in women than in men). It leads to progressive invalidity in its chronic stage, a life with disabilities in a wheel chair and enormous socio-economic burden. In Europe, the total costs of MS are about 14.6 billion EUR as MS is a progressive disease with a poor prognosis. The European Commission is aware that demyelinating diseases like MS are a burden for patient, their families and friends but also for the national health care systems as this disease concerns predominantly younger adults. Therefore, the EU supports and funds research and development in the field of demyelinating diseases to develop novel therapies and rehabilitation and innovative medical devices to improve the quality of life of MS patients and to reduce the socioeconomical burden.


My question is not answered, who do I contact if I have other questions?

For more questions you can always contact the European Multiple Sclerosis Platform (EMSP) at