Another old, cheap generic is being prepped for an FDA application — made over into a ‘new’ drug for ADHD and narcolepsy
Can an old, cheap generic obesity drug pulled years ago from the US market be tweaked and made over into a brand new therapeutic able to compete for a share of the multibillion-dollar ADHD market?
NLS Pharma aims to find that out.
Mazindol was first developed way back in the 1960s by Sandoz as an immediate-release obesity drug designed to shed pounds fast. A little less than a decade ago, the FDA determined that while the therapy — sold as Sanorex — had been pulled from the US market, it wasn’t due to safety or efficacy reasons, leaving it wide open to a generic application from a discount supplier.
But now Swiss biotech NLS says it has tweaked the aging generic with a controlled release formulation and has gathered promising mid-stage data to show how it can work as an alternative to the amphetamines used in currently marketed ADHD drugs.
Gregory Mattingly, an NLS study investigator, told Reuters that in a Phase II with 85 patients the drug reduced symptoms of ADHD by more than half, much better than the 15.8% rate of patients in the placebo arm.
NLS got its IND approved for this drug — which acts like the brain chemical orexin and is now dubbed NLS-1 — by the FDA last year, saying that it also had plans to develop the therapy for rare cases of narcolepsy. And on July 11, the biotech announced that the FDA had followed up with an orphan drug designation for mazindol, which provides a package of incentives aimed at encouraging the development of new drugs.
NLS has touted the drug as an alternative to the amphetamines used in drugs like Adderall from Shire, able to escape the controlled substance regulations that can make it harder to market these therapies. It is, in its original form, a stimulant, increasing heart rate and blood pressure while tamping down on appetite.
NLS CEO Alex Zwyer isn’t hiding just how old this drug is. In fact, he’s highlighted it as a definite plus in the company’s favor. Zwyer noted in a release last year:
Mazindol has been used off-label in narcolepsy since the 1970’s, and it is our goal to make it available to all narcoleptic patients.
NLS still has registration studies to complete before it can angle for an approval, but if it makes the last leg of the clinical journey it has the potential to remind people of Marathon, which took an overseas generic, hustled it through an abbreviated development plan for Duchenne muscular dystrophy and came up with an approval to sell it for $89,000. The resulting scandal brought Marathon’s house down, and PTC Therapeutics bought it for $140 million in cash. They’re proceeding with the launch.