Thursday, October 15, 2020 10:14:04 AM
Although more precise data of the Parkinson's disease dementia (PDD) study aren't yet available, the corporate announcement that blarcamesine demonstrated both safety and efficacy in a legitimate double-blind clinical trial now validates Anavex science. Until now, it had been demonstrated only in animal models of CNS (central nervous system) diseases. Now, in real humans, with a debilitating CNS disease.
Results are claimed to be statistically significant. Adverse events (side effects), if any, were inconsequential. Blarcamesine is safe at doses 30 to 50mg.
Inasmuch as there is no truly effective treatment of PDD, other than some antipsychotics, things are aligning for eventual FDA approval of blarcamesine. For that, three things must happen: 1. The new drug must have been proven safe in humans. That, now, has been done. 2. The new drug must have been proven effective in treating targeted disease symptoms. Now so proven. Lastly, 3, the new drug must match or exceed the efficacies of existing treatments. Accomplished.
Next will be similar results from the Rett syndrome trial. Then, finally, the results from the long-term Alzheimer's study.
The Anavex sigma-1 agonist mechanism(s) of action have been fruitfully demonstrated now in real humans, with statistical significance. Chance results and placebo effects are no longer in play. The Anavex science is real. The Anavex drug pipeline has no leaks.
Will be interesting to see how the general news press tells of this.
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