) Investigational New Drug (IND) application for Metadoxine
Extended Release (MDX) has been cleared by the U.S. Food and Drug
Administration (FDA) recently. The IND application was filed on
Feb 7, 2014, for the treatment of cognitive dysfunctions, such
as, attention deficit hyperactivity disorder (ADHD) and Fragile X
The acceptance will allow for the initiation of phase III
studies in adult patients with ADHD in the U.S. Two large phase
III studies have been chalked out. Enrolment of patients is
expected to begin in the first quarter of 2014 in one of these
studies. In this phase III, randomized, multicenter,
double-blind, parallel, fixed-dose study, MDX 1400 mg will be
evaluated in adults with ADHD as compared to placebo for a period
of 6 weeks.
This IND has also cleared the pathway for additional studies
in other related indications, which also include a planned study
in Fragile X Syndrome. The FDA has granted orphan drug status to
MDX for the treatment of Fragile X Syndrome.
MDX has completed phase II studies to treat ADHD. The two
placebo-controlled phase II studies revealed that MDX has
substantial efficacy and tolerability attributes in adults with
ADHD. MDX data was statistically significant in a phase IIb study
in adults with predominantly inattentive attention deficit
In a preclinical abuse liability study, it was demonstrated
that MDX has substantially less potential for abuse than
methylphenidate, which is a common stimulant ADHD medication.
Alcobra carries a Zacks Rank #3 (Hold). Investors looking for
better-ranked stocks in the biopharma sector may consider
Gilead Sciences Inc.
). Gilead Sciences carries a Zacks Rank #2 (Buy) while Shire and
Alkermes carry a Zacks Rank #1 (Strong Buy).
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