U.S. Based Phase 3 Clinical Trial in Adult ADHD Expected to Begin Enrolling Patients in 1Q14
TEL AVIV, Israel I March 6, 2014 I Alcobra Ltd. (ADHD), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate Metadoxine Extended Release (MDX) to treat cognitive dysfunctions, such as Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced today that the US. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for MDX. 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 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.”
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.
About Alcobra Ltd.
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. MDX has completed Phase II studies to treat Attention Deficit Hyperactivity Disorder. The company was founded in 2008 and is headquartered in Tel Aviv, Israel. For more information please visit the Company’s website, www.alcobra-pharma.com, the content of which is not incorporated herein by reference.
SOURCE: Alcobra
Post Views: 112
U.S. Based Phase 3 Clinical Trial in Adult ADHD Expected to Begin Enrolling Patients in 1Q14
TEL AVIV, Israel I March 6, 2014 I Alcobra Ltd. (ADHD), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate Metadoxine Extended Release (MDX) to treat cognitive dysfunctions, such as Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced today that the US. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for MDX. 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 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.”
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.
About Alcobra Ltd.
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. MDX has completed Phase II studies to treat Attention Deficit Hyperactivity Disorder. The company was founded in 2008 and is headquartered in Tel Aviv, Israel. For more information please visit the Company’s website, www.alcobra-pharma.com, the content of which is not incorporated herein by reference.
SOURCE: Alcobra
Post Views: 112
