Recent reports question whether Aricept 23mg is safe and effective to treat Alzheimer's Disease.
Aricept is the brand name drug for donepezil, an acetylcholinesterase inhibitor, which is prescribed for patients suffering from Alzheimer's Disease (AD). Donepezil works by blocking the action of acetylcholinesterase, an enzyme that breaks down acetylcholine, a brain chemical believed to be important for memory and thinking. The effect of the drug is to cause acetylcholine levels to remain high for longer periods of time. This is believed to help in the proper function of the human nervous system, including the brain.
Aricept is manufactured and marketed by Eisai Co. and Pfizer Inc., two pharmaceutical giants, and was first approved by the FDA on November 25, 1996 for the treatment of mild to moderate AD, at a dose of 5 or 10mg once a day. On October 13, 2006, Aricept was approved for severe AD at a dose of 10mg once a day.
The patent on Aricept 5 and 10mg was set to expire on November 25, 2010. Once the patent expired, generic manufacturers could market donepezil in those dosages, and Pfizer and Eisai would lose considerable market share and revenue.
Under federal law, new doses of previously approved drugs, not reproducible from currently marketed doses, may be given a three-year period of exclusivity during which generic competitors are not permitted to manufacture and sell the same new dose. Thus, Pfizer and Eisai came up with a plan to seek approval for an unusual 23mg dose of Aricept—an odd number, yet a dose that could not be reached by combining currently marketed 5mg and 10mg pills—thereby extending for three years the marketing exclusivity for the 23mg dose of Aricept, and continuing a revenue stream as well.
On July 23, 2010, just a few months before patent expiration in November 2010, Aricept 23mg was approved for moderate to severe AD. This occurred even though Aricept 23mg received highly critical reviews from both the FDA clinical and statistical reviewers; both clinical and statistical reviewers recommended against approval, and the one clinical study submitted to support the efficacy of Aricept 23mg failed to establish that the dosage had any clinically meaningful benefit beyond a lower dose, and in fact, presented more serious and life-threatening risks to AD patients.
Since the approval of Aricept 23mg, and its launch in August 2010, Pfizer and Eisai have embarked on an aggressive and unrelenting marking campaign to collect as much revenue as possible from Aricept 23mg despite the fact that it is no more efficacious than lower doses of generic donepezil (which are considerably less expensive that Aricept 23mg), and poses substantially more risks, including death, to elderly and disabled AD patients.
If you or a loved one used Aricept 23mg, you may have a legal claim against the manufacturer even if you have not suffered any physical injury. Call us today for a free legal consultation.