FDA halts trial of Alcobra's ADHD drug
- The Food and Drug Administration has put a full clinical hold on investigational new drug applications for Alcobra Ltd.'s extended release formulation of metadoxine, in development for ADHD and Fragile X syndrome, due to concerns about preclinical neurological findings, the Israeli company said this week.
- According to a note from Jefferies, the hold could be related to neurotoxicity seen in a preclinical rat study of the drug. Alcobra has already enrolled nearly 500 patients in its Phase 3 study of MDX in ADHD and made clear the verbal notification from the FDA was not related to any observed clinical safety data.
- Alcobra shares plunged downward in value by nearly 46% in Thursday trading after news of the hold was reported by the company.
This is yet another challenge for Alcobra's attempts to get MDX (metadoxine extended release), its lead drug, closer to the market. In 2015, MDX failed to beat out a placebo in a 62-week Phase 2 trial of the drug in ADHD linked with Fragile X syndrome, failing to meet primary and secondary endpoints.
There have been no signs of neurological issues in the Phase 2 and Phase 3 clinical trials of the agent,according to the company. Immediate-release metadoxine has been used for treating acute alcohol intoxication for several decades.
Alcobra said it received verbal notice of the hold from the FDA's Division of Psychiatry Products but the company has not yet received any written notice.
Jefferies predicts Alcobra could receive approval for MDX in 2020, two years later than previously estimated.
Alcobra had just over $60 million in cash and equivalents at the end of the second quarter, and spent roughly $4 million in R&D costs related to the Phase 3 ADHD study.
GlobalData predicts the world ADHD market could be worth $13.9 billion by 2024, growing at a 8.5% rate. This is likely to be driven, at least in part, by increased understanding of adult ADHD and improvements in diagnosis and treatment.
However, many of the drugs on the market and in the pipeline are stimulants in various formulations. Shire's SHP465, for example, is an amphetamine-based oral formulation. If Alcobra can get its troubled drug through to the market, then its position as a non-stimulant and lack of potential for abuse or addiction could give it an edge.
- Alcobra Statement
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