NLS Pharma has posted some positive data for its ADHD candidate mazindol CR, which it hopes will have better luck than it did for obesity and narcolepsy after it was pulled off the market.
The biotech believes the drug regulates the orexins system in the hypothalamus, something that regulates arousal, wakefulness and appetite.
In its latest test, 85 patients were treated and assessed over six weeks, with the primary endpoint being change from baseline in the ADHD-RS-DSM5 score.
The mean change from baseline in this score at day 42 was a statistically significant -13.2 in favor of mazindol versus placebo.
The midstage data showed that the majority (55%) of patients on its med had greater than 50% reduction in ADHD symptoms after two weeks, while 70% showed a response after one week, against 21% for placebo.
The most common adverse events were constipation, nausea, fatigue and increased heart rate.
This builds on data from a previous mazindol test in 24 children in France who were severely affected by ADHD and unresponsive to the stimulant methylphenidate. In this test, the biotech said, and over one week the children saw a 90% reduction over baseline of 24.6 points on the ADHD rating scale.
The biotech hopes its med can match stimulants, such as Shire’s Adderall and Vyvanse, in treating the disorder, but with fewer safety risks.
Stimulants, which can boost levels of dopamine (and therefore attention) are generally seen as being more effective than non-stimulants, but come with some potentially nasty adverse events and the risk of abuse. There are already non-stimulants on the market, such as Lilly’s Strattera.
Mazindol has been on the market before, under the brand name Sanorex, although it was withdrawn from sale. The FDA says, however, that its withdrawal was “not due to safety or efficacy” reasons.