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news.Israel-based biopharmaceutical firm Alcobra (ADHD) has received approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for Metadoxine Extended Release (MDX) to treat cognitive dysfunctions.
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The FDA approval will allow the company to start its US based Phase III study in adult patients with ADHD, and patient enrollment is expected to start shortly.
Alcobra is mainly focused on the development and commercialization of its proprietary drug candidate MDX.
Alcobra president and chief executive officer Yaron Daniely said the FDA’s acceptance of the company’s IND marks an important development milestone for MDX.
"The IND will also pave the way for additional studies for other related indications, including a planned trial in Fragile X Syndrome," Daniely said.
The company said that unlike the most commonly prescribed ADHD medications, MDX is not a stimulant and it has a new mechanism of action that neither targets dopamine nor norepinephrine.
MDX has showed significant efficacy and was generally well tolerated in two separate placebo-controlled Phase II trials in adults with ADHD.
In addition, MDX has showed significant efficacy following the first dose.