Privately-held Swiss biotech NLS Pharma believes it could be about to change the treatment landscape for attention deficit hyperactivity disorder (ADHD) after its lead investigational compound, NLS-1 (mazindol CR), met all primary and secondary endpoints in a Phase II clinical study.
The trial concerned is a double-blind placebo-controlled Phase II study to determine the efficacy, safety, tolerability and pharmacokinetics of mazindol in adults with DSM-5 ADHD. Data showed most patients on this medicine had greater than 50% reduction in ADHD symptoms after two weeks, while 70% responded after one week, compared to 21% for placebo.
Currently the drugs classified by the US Food and Drug Administration as schedule 2 stimulants are the best-known and most widely used medications for this condition, and while they have been proven effective for many symptoms, they produce optimal functioning in roughly just one in four with ADHD. There are also concerns about the potential for misuse and abuse of these medications. Ireland-incorporated drugmaker Shire's (LSE: SHP) Adderall (mixed amphetamine salts) and Vyvanse (lisdexamfetamine) are examples of existing stimultants.
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