The US Food and Drug Administration (FDA) has cleared the Alcobra Ltd's Investigational New Drug (IND) application for Metadoxine (MDX) extended release to treat cognitive dysfunctions, such as Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome. This step will allow for the initiation of US clinical trials.

"The FDA's acceptance of our IND marks an important development milestone for MDX," said Dr. Yaron Daniely, president & chief executive officer of Alcobra. "It allows us to commence our US based phase 3 study in adult patients with ADHD, and we expect to enroll the first patients shortly. The IND will also pave the way for additional studies for other related indications, including a planned trial in Fragile X Syndrome."

Unlike the most commonly prescribed ADHD medications, MDX is not a stimulant. MDX has a novel mechanism of action that neither targets dopamine nor norepinephrine. MDX has demonstrated significant efficacy and was generally well tolerated in two separate placebo-controlled phase 2 studies in adults with ADHD. Additionally, MDX has demonstrated significant efficacy following the first dose.

Alcobra Ltd. is an emerging biopharmaceutical company primarily focused on the development and commercialization of a proprietary drug candidate, MDX (Metadoxine Extended Release (MG01CI)), to treat cognitive dysfunctions including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome.