When Will Anavex 2-73 Get Prescribed?
Let’s assume, quite reasonably, that the upcoming Phase 3 clinical trial, using updated designs and measurements, produces data similar to the Australian trial. Should those data be similar, FDA approval would be forthcoming, inasmuch those data already eclipse the existing standard of care data, from any of the four standard of care Alzheimer’s drugs, primarily Aricept (donepezil).
Presently, comments are being posted here with concerns regarding the fraction of trial participants with superior cognition improvements, and strength of those. The newly-released data show that Anavex 2-73 did not produce universal cognition improvement; only for fraction of the patients in that study. Therefore, the drug is perceived or presented as not as powerful or universally applicable as hoped or presumed by some.
But those data and findings are likely to be clinically irrelevant, when physicians have Anavex 2-73 available for each and every dementia patient they treat.
It won’t be like this. “Mrs. Jones, it was good that you brought your husband in here. He does have early-stage cognitive decline. He is in the first stages of Alzheimer’s, unfortunately. But in a year or two, there is great hope for him. We now have this new drug, Anavex 2-73, and for 25 to 50% of mid to mild Alzheimer’s patients, it gives wonderful stabilization of thinking, even improving it in many. So just take care of your husband a bit longer, until we assess that he’s progressed to the mid to mild stages of Alzheimer’s. Then, replicating the big Anavex study last year, we’ll start him on the drug. Right now, he’s not suffering enough yet. Next patient, please.”
No, there will be absolutely no reason not to begin Anavex 2-73 treatment at the very first indication of dementia onset. In short, clinical use of the drug will not be restricted to a patient cohort paralleling the mid to mild stage Alzheimer’s patients in the FDA-approval Phase 3 study. The drug will be given at the very earliest stages of Alzheimer’s dementia, for which there is currently no clinical response data.
There is every good reason to believe that early, even prophylactic administration of Anavex 2-73 will yield symptomatic relief greater than seen in the Phase 3 clinical data. Those data will have been taken from patients with well-developed, rather advanced Alzheimer’s symptomotology. Ethically and practically, physicians won’t be waiting to prescribe Anavex 2-73 only to those with advanced symptoms. They will be writing prescripts at the earliest signs of any geriatric dementia — with a consequently greater likelihood of profound relief. Early detection; early treatment. No reason to limit treatment to populations used in the clinical trial. Consequently, results will be better than the Phase 2 and Phase 3 data. Early treatment will be better treatment. Amyloid plaques and tau tangles will be much smaller; far more amenable for successful Anavex treatment.