- NLS Pharma is forging ahead into late-stage testing for its drug for improving focus, bolstered by newly released data demonstrating the treatment's strong safety and efficacy profiles.
- Patients taking Mazindol Controlled Release had, on average, significantly more reduction in their scores on the Attention Deficit Hyperactivity Disorder Ratings Scale than those receiving placebo, amounting to an effect size of 1.09. After six weeks, 55% of participants in the experimental arm saw at least a 50% decline in their scores versus 15.8% in the control arm. There were also no serious adverse related to Mazindol treatment.
- Mazindol works in two ways: it prevents the reuptake of the neurotransmitters serotonin, norepinephine and dopamine while also promoting a receptor called orexin-2, which helps regulate sleep and eating. Though ADHD drugs generally fall into either stimulant or non-stimulant categories, Mazindol's dual mechanism of action means it " doesn't fit the description or the profile of a stimulant or a non-stimulant either," at least in NLS' view, CEO Alex Zwyer said in an interview.
The ADHD space is becoming increasingly crowded as drugmakers work to develop safer, more long-lasting treatments for the disease. Stimulants have been the dominant players for a while due to their efficacy, but more serious side effects have also spurred development of non-stimulants like Eli Lilly's Strattera (atomoxetine HCl).
"Every company in the ADHD space for the last 20 or maybe 30 years was looking for a drug which is as effective as a stimulant but maybe with a safety profile more comparable to a non-stimulant," Zwyer said. "To my knowledge so far, that drug has yet to be discovered."
Zwyer added that his company plans to push its drug into Phase 3 testing next year, both for ADHD and narcolepsy.
Bringing an ADHD medication to market would not only allow NLS to shed its clinical-stage title, but would also stand to bring in some solid revenues. Novartis' ADHD drugs Ritalin and Focalin, for instance, brought in $282 million during 2016. In the same period, Johnson & Johnson's Concerta (methylphenidate)saw sales of $863 million, while Shire's Adderall Extended Release sported $364 million in sales.
And it looks as though the ADHD space will continue to be profitable. A recent report from data analytics firm GlobalData, for example, pegged the ADHD drug market across seven of the world's biggest pharmaceutical spenders — France, Germany, Italy, Japan, Spain, the UK and the U.S. — to balloon from 2014 to 2024 at a compound annual growth rate of 8.5%, ultimately hitting $13.9 billion by the latter year.
Mazindol benefits from having a previous version of it on the market, though it was pulled in U.S. in the early 2000s for commercial reasons. Still, it will need all the help it can get as heavy hitters move their own ADHD meds toward market. Shire has a PDUFA date sometime in the second quarter for its SHP465 (long-acting amphetamine).