Alcobra Ltd.’s (ADHD) 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 Syndrome.
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 hyperactivity disorder.
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 companies like Gilead Sciences Inc. (GILD), Shire (SHPG) and Alkermes (ALKS). Gilead Sciences carries a Zacks Rank #2 (Buy) while Shire and Alkermes carry a Zacks Rank #1 (Strong Buy).