When was namenda fda approved

Pharmacopsychiatry ; 33 3 : Winblad B, Poritis N. Memantine in severe dementia: results of the 9M-Best Study Benefit and efficacy in severely demented patients during treatment with memantine. Int J. Geriatr Psychiatry ; A double-blind, placebo-controlled multicentre study of memantine in mild to moderate vascular dementia MMM Int Clin Psychopharmacol.

Lundbeck Takeda Pharmaceuticals U. I am optimistic about the introduction of memantine, and think it is more likely to affect a if not the basic trigger factor for onset of the disease. I plan to review results of long-term use of memantine in Germany, where I believe it has been used for some years, to see if there has been much success in its use.

There has been a lot of emphasis on early diagnosis of Alzheimer's disease with the expectation that early intervention could provide a better chance in averting or even preventing onset of the disease. If basic research indicates that the NMDA receptor is involved in the pathogenesis of the disease, and early testing can indicate a person has Alzheimer's disease, there would seem to be a potential benefit for early treatment.

It would be especially difficult to withhold treatment if the medicine is safe and not likely to have any bad side effects. This is just my initial impression, and I certainly plan further review for a more informed opinion. NPI scores for agitation and delusion also improved on memantine, as did behavioral symptoms. The investigators concluded that memantine slows the clinical deterioration at this stage of AD.

The open-label extension phase of this study enrolled patients; it showed that a meaningful clinical benefit lasted for a year. Patients who switched to memantine from the blinded study's placebo arm improved on cognitive, functional, and global measures compared with their projected rate of continued decline see Apr story on Reisberg et al. Trials of memantine in mild to moderate AD yielded mixed results.

Two six-month, Phase 3 studies in patients with mild to moderate AD showed modest treatment benefits for memantine over placebo. The other trial, conducted in patients in Europe, showed benefits of memantine only at interim time points, and fell short of statistical significance at study completion. In Forest Laboratories filed for FDA approval of memantine as a treatment for mild AD, but in the agency issued a non-approvable letter, requiring a confirmatory study.

The drug was never formally approved for the early stages of AD, but is frequently prescribed at this stage. Whether memantine is clinically useful in mild AD is controversial, as meta-analyses have reported conflicting conclusions Doody et al.

Memantine was studied in combination therapy with the cholinesterase inhibitor donepezil. The first U. This is the first combination drug trial for AD to yield positive results Tariot et al.

Pharmacoeconomic studies have been largely positive. The U. Other authors reported that memantine treatment reduced caregiver time and other societal costs, as did combination memantine-cholesterol inhibitor treatment. Memantine has been prescribed off-label for frontotemporal dementia, and an open-label trial had suggested a possible benefit for the disease's psychiatric aspects.

However, in a subsequent randomized controlled trial of 20 mg memantine daily in 81 patients, the drug had no benefit on neuropsychiatric symptoms while worsening cognition in some patients Boxer et al. Two Phase 3 studies tested this drug in more than 2, patients with glaucoma, but the results reportedly fell short of being able to support a marketing application for this disease see clinicaltrials. Memantine was studied unsuccessfully for neuropathic pain and diabetic neuropathy Rogers et al.

At least one early clinical trial of memantine in patients with vascular dementia appears to have shown cognitive improvement, but no further studies on this indication have been reported in the past 10 years Wilcock et al, Trials of memantine in adults with Down's syndrome were negative see Jan news story on Hanney et al.

For a listing of clinical trials of memantine, see clinicaltrials. To make a comment you must login or register. Improvement in behavioural symptoms in patients with moderate to severe Alzheimer's disease by memantine: a pooled data analysis. Int J Geriatr Psychiatry.