Alcobra Finishes Follow-up Visits on Phase III Trial on MDX

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Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.

Alcobra Ltd. (ADHD) recently announced that all scheduled follow-up visits have been completed for patients enrolled in the phase III trial on Metadoxine Extended Release (MDX) for the treatment of adults suffering from attention deficit hyperactivity disorder (ADHD).

Alcobra expects to complete data verification, database lock and top-line statistical analysis from the trial in approximately two weeks.

The randomized, placebo-controlled trial (n=300) is being conducted at 18 sites in the U.S. and two in Israel wherein patients were randomized to receive either 1400 mg MDX or placebo over six weeks followed by a two-week safety follow-up and preceded by a two-week screening period.

The primary endpoint measure of the trial is the Conners' Adult ADHD Rating Scale which measures the presence and severity of ADHD symptoms while its secondary endpoints include the computerized Test of Variables of Attention.

We note that Shire plc (SHPG) holds a strong position in the ADHD market. Shire’s Vyvanse is approved in the US as a maintenance treatment for ADHD in adults as well as children and adolescents (6–17 years). Other ADHD drugs in Shire’s portfolio include Adderall XR and Intuniv.

We expect investor focus to remain on further pipeline updates from Alcobra.

Alcobra holds a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Jazz Pharmaceuticals (JAZZ) and Pacira Pharmaceuticals (PCRX). Both carry a Zacks Rank #2 (Buy).

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