Alcobra Says FDA Clears IND Application For Metadoxine Extended Release

(RTTNews) - Alcobra Ltd.(ADHD) announced that the US. Food and Drug Administration or FDA has cleared the company's Investigational New Drug or IND application for Metadoxine Extended Release. This step will allow for the initiation of US clinical trials.

Alcobra is an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate Metadoxine Extended Release or MDX to treat cognitive dysfunctions, such as Attention Deficit Hyperactivity Disorder or ADHD and Fragile X Syndrome.

"The FDA's acceptance of our IND marks an important development milestone for MDX...It allows us to commence our U.S. 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," said Dr. Yaron Daniely, President & Chief Executive Officer of Alcobra.

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.