Insomnia Relief, Alone, Assures FDA Approval
Consider several well-established facts.
1. In the Australian trial, those Alzheimer’s patients suffering from insomnia no longer did while taking Anavex 2-73.
2. In that study, there were no reports of any participant on Anavex 2-73 that suffered from insomnia. All slept well.
3. Insomnia and nocturnal wandering are severe complications of Alzheimer’s disease.
4. Anavex 2-73 exhibited only low-level, infrequent side effects in the Australian clinical trial. Side effects are not a disqualifying factor.
With these, it is reasonable to presume FDA approval of Anavex 2-73 consequent to the up-coming double-blind Phase 3 Alzheimer’s clinical trial, should, per chance (well, exact cause), restoration of normal sleep patterns be the single, only symptom improvement.
Because the drug is safe (no side effects of consequence), is easily administered (orally, not by injection), and would prove universal restoration of normalized and thorough sleep patterns, the drug would gain FDA approval for that symptomatic improvement, alone.
Keeping Alzheimer’s patients from getting up and wandering around at Alzheimer’s care centers is a major, intractable problem. The disruption of normal sleep then causes consequent other problems.
Alzheimer’s care givers and treatment facilities would be delighted to be able to eliminate the insomnia problem. The use of the new drug would improve the standard of care for these patients.
Approval of a new drug must a) be safe, few or no side effects, and b) exceed the current “standard of care,” give better treatment results than currently available drugs.
None of the four Alzheimer’s treatment drugs are noted for effectively treating insomnia or nocturnal wandering. Other than conventional anti-insomniac drugs, each of which have severe and lasting side effects, Anavex 2-73 can stand alone and above, creating a new, better standard of care.
Let’s watch (and anticipate) the results of all three of the upcoming clinical trials. Will firm sleep be recorded in most or all participants? Very, very likely. The stochastics (chances) for this are high. What are the chances that all of the Australian participants only incidentally gained sleep benefits; that any larger population of Alzheimer’s patients might have a more normalized (Gaussian, bell-shaped-curve) distribution? The chances of all of the Australians gaining rather complete sleep profiles, by chance other than exact Anavex cause are extremely tiny. The numbers tell. ‘Twern’t just chance.
