Alcobra Ltd (Tel Aviv) has filed with the SEC to raise money in the stock market to test Metadoxine SR (slow release) for use with ADHD sufferers. The money will allow Alcobra to run a Phase II/III trial in preparation for requesting FDA approval for use in ADHD. They intend to raise $15-$20 million US. (Source: Globes) Metadoxine SR is the only product this company has and, of course, it’s not on the market until the FDA approves it. Yet the company is already valued at $100 million before raising money. This might give one an idea of how profitable the ADHD medicine market it.
Metadoxine is presently used for for acute alcohol intoxication and withdrawal — it excels in clearing the blood of alcohol and helping the liver recover.
Cautiously positive signs for long-term use, when used in the treatment of acute and chronic alcoholism, “Metadoxine seems to be safe; in more than 15 years of post-marketing surveillance only minor specific and reversible events were monitored in patients exposed to treatment.” (PubMed.gov)
In the Phase 2 trial, completed, the most common side effects were nausea and insomnia. It did not seem to increase blood pressure or decrease appetite as is sometimes seen in other drugs used for ADHD. (Source: MedScape) It seems to me (not a doctor) that nausea is often linked with decreased appetite, but if the study says not then who am I to question???