Alcobra Ltd.’s (ADHD) shares plunged 56.6% immediately after the company announced disappointing top-line results from a phase III study on metadoxine extended release (MDX) for the treatment of adults suffering from attention deficit hyperactivity disorder (ADHD). Although shares were up 6.4% in the subsequent trading session, overall shares are down 53.9% since the announcement.
In the randomized, placebo-controlled study, adult ADHD patients were administered either 1400 mg of MDX or placebo for six weeks. The primary endpoint of the study was the change from baseline measured by the Conner's Adult ADHD Rating Scale (CAARS-INV).
Alcobra stated that MDX showed a statistically significant improvement in ADHD symptoms compared to placebo in a modified Intent To Treat patient population (n=293).
We note that Alcobra achieved the above result from an analysis of the modified patient population after omitting four placebo-treated patients who had reportedly showed “extreme placebo responses.” Although Alcobra said that the extremely large placebo responses of the four patients were inconsistent with the results obtained from previous studies on MDX or other agents for ADHD, we note that MDX failed to show an improvement in ADHD symptoms compared to placebo in the patient population (n=297) before the post hoc exclusion.
Detailed results from the study will be available shortly.
Meanwhile, Alcobra is evaluating MDX in two other indications – adolescents suffering from ADHD and adolescents and adults suffering from Fragile X Syndrome. These studies should be completed by year end. Metadoxine has orphan drug status in the U.S. for the treatment of Fragile X Syndrome.
The market for ADHD is dominated by the presence of Shire plc (SHPG) which has ADHD treatments like Vyvanse, Adderall XR, Intuniv and Equasym.
Alcobra holds a Zacks Rank #2 (Buy). Some better-ranked stocks in the pharmaceutical sector are Lannett Company, Inc. (LCI) and Pacira Pharmaceuticals, Inc. (PCRX). Both carry a Zacks Rank #1 (Strong Buy). Shire also carries a Zacks Rank #1.
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