Mazindol CR, an alternative treatment option for ADHD, is set to transform the lives of millions.  Alex Zwyer – Co-founder and CEO of NLS Pharmaceutics Ltd. (NLS) – explains the discovery and benefits of his organisation’s revolutionary medication.

Attention Deficit Hyperactivity Disorder or ADHD is a neuro behavioural disorder characterised by inattentiveness, hyperactivity and impulsiveness – the levels of which are diagnosed as being inappropriately high in relation to the developmental age of the individual.

A report published by the Journal of the American Academy of Child & Adolescent Psychiatry, 2014 suggests that over 10 million adults in the USA suffer with ADHD. The condition affects an estimated 11 per cent of American primary school children and is also commonly prevalent within the prison population. Taking into consideration that over 40 per cent of adult male long-term inmates are said to exhibit acute ADHD symptoms in conjunction with a range of co-existing brain based psychological disorders, the consequential impact on society is costly and increasingly far reaching.

With a career spanning more than 20 years, the creative leadership of Alex Zwyer, Co-founder and CEO, places Swiss-based, NLS at the forefront of pioneering research and development into treatments for ADHD.  In this interview, Alex tells us why ADHD is such an important condition to manage, discusses disruptive technology addressing these unmet medical needs together with his perspective on NLS’s secrets to success and its ultimate aims and objectives.

Could you tell us a little bit about ADHD and the need to control and manage this disorder.

ADHD is a chronic neurological condition marked by persistent inattention, hyperactivity and impulsivity. The condition does tend to be genetic and where diagnosed within a family, there is a strong likelihood that other family members will also have the condition. Children with ADHD often have difficulties coping with school life, the disorder affecting their education and social and emotional development.

The long-term effects of ADHD are detrimental both to the individual and to society as a whole.  Numbers of patients diagnosed are rising, as are associated issues of depression, anxiety, violence and drug and alcohol abuse. This places a heavy burden on both families and the state in terms of educational support, finances, productivity, healthcare, etc.  Developing safe, effective treatment options which can improve the quality and longevity of life of ADHD patients is therefore vital.

Could you give us a bit of background into NLS Pharmaceutics Ltd. (NLS) and how the organisation became specialists in alternative treatments for ADHD?

NLS was formed in 2015 recognising the unmet medical needs in the ADHD space.  Available treatments were only effective for a minority of patients; the side effects of stimulant drugs being the major concern and prohibiting factor. Our dedicated team of researchers, drug developers and commercial leaders are passionate about pushing the boundaries to develop life changing treatments which will enhance the quality of life for ADHD patients,

Dr. Eric Konofal, our co-founder, is a renowned medical opinion leader in the field of child psychopathology and adolescent and paediatric sleep disorders and a certified neurologist.  His extensive experience involving clinical trials led to him considering Mazindol, a drug previously successful in treating short term obesity, for use in ADHD patients.  As results from a small initial study were promising, we were inspired to progress to a larger Phase 2 trial in the US, which again confirmed our findings – Mazindol CR could well be a potential game changing disruptive technology addressing the vast unmet needs of ADHD patients.

What differentiates Mazindol CR from traditional ADHD treatments and how does it work?

Medications currently licenced for treating ADHD symptoms are traditionally either stimulant based drugs such as methylphenidate and amphetamine products, or non-stimulant treatments.  Whilst stimulants are effective at helping ADHD patients become calmer and less impulsive through increasing brain activity, their use does incur side effects. There is also a significant risk of abuse and misuse of these drugs, and therefore a safety aspect to consider.  All in all, it may not be practical or wise to prescribe stimulant drugs to the entire population of ADHD patients.

Non-stimulant treatment options are generally not as effective as stimulants. However, there is also a severe safety risk as side effects could potentially be life-threatening – suicidal thoughts, severe liver injury, and the risk of a serious cardiovascular event.

In contrast, Mazindol CR has a dual mechanism of action – it has an effect on dopamine and norepinephrine, two main validated neurotransmitter targets of ADHD and also promotes a receptor called orexin-2 and binds strongly to serotonin.  Consequently, Mazindol CR neither fits the typical C-2 stimulant profile nor is it a non-stimulant.

Its unique properties showed significant benefits after just one week – a quarter of the time which other non-stimulants took to activate.  Side effects were well-tolerated and symptoms notably decreased in the vast majority of trial participants.

What are the next stages for bringing such an exciting, revolutionary treatment to the market and what is your ultimate ambition?

Our Phase 3 trial will continue to study the efficacy and safety of Mazindol CR as well as an evaluation of dosage recommendations.  We anticipate that results from Phase 3 will confirm our beliefs.  Mazindol CR is effective at treating ADHD symptoms, lowers the potential for abuse and misuse and transforms the process of patient management through easier to acquire prescriptions.

Our ultimate ambition is not only to establish Mazindol CR as a revolutionary, efficient and safe alternative to current ADHD treatments, but to continue with our ground-breaking research, initiatives and studies into ADHD, its management and understandings of this debilitating disorder.

As a progressive forward-thinking organisation and recipient of many prestigious sector awards, what would you consider to be the secrets of NLS Pharmaceutics success?

I believe our success reflects the dedication and collaboration of our own outstanding team and their ability to liaise and work closely with our industry partnerships and global academic research centres.

Coupled with this, we have a thoroughly patient centred approach.  Our patients are at the heart of all we do and that means striving to find safe, effective ways of managing ADHD. Our core objective is to improve and transform the quality of life for millions of sufferers through ethical, moral and responsible practices.

Further information on NLS Pharmaceutics Ltd. focus, strategy, up to date news and study on the effects of Mazindol CR can be found at https://nlspharma.com/