NEWS
09/09/1993

<TITLE>FDA Announces Approval of TACRINE HYDROCHLORIDE</TITLE>
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P93-37                              Food and Drug Administration
FOR IMMEDIATE RELEASE               Susan Cruzan (301) 443-3285

     
     The Food and Drug Administration today announced the approval
of tacrine hydrochloride, the first drug approved specifically to
treat symptoms of Alzheimer's disease.  
     Alzheimer's disease, a progressive condition affecting memory,
judgment and the ability to reason, affects an estimated four
million Americans.  Tacrine was found in two controlled trials to
provide a small but clinically meaningful benefit for some patients
with mild to moderate Alzheimer's disease.   
     "Tacrine is the first drug shown to have some effect on the
disease's devastating symptoms," said FDA Commissioner David A.
Kessler, M.D.  "It is not a cure for Alzheimer's disease, but it
provides some relief for patients and their families." 
     The conclusion that tacrine is effective for the treatment of
symptoms of mild to moderate Alzheimer's disease was based on
studies showing that the drug is superior to a placebo in
influencing measurements designed to assess antidementia drugs.  
These measurements include a specific performance test that
assesses memory and reasoning ability, and an overall assessment of
function based on an interview by a trained clinician.  
                             -MORE-
 
                                        Page 2, P93-37, Tacrine
     An advisory panel recommended approval of tacrine in March
1993 based on new studies submitted by the manufacturer, Warner-
Lambert Co. of Morris Plains, N.J., which will market the drug
under the trade name Cognex.  The firm conducted these studies
after an advisory committee concluded in July l991 that the
available evidence based on relatively low doses did not support
approval of the drug.  The committee recommended that the company
study use of higher doses over a longer period of time.  In one of
the new studies, which lasted 30 weeks, patients were given between
80 and 160 mg. of the drug.  
   Today's approval comes seven months after the manufacturer
submitted data using the higher doses.
     Because tacrine can cause mild liver toxicity, which has been
reversible if tacrine treatment is withdrawn promptly, the labeling
for the drug recommends an escalating dosing regimen with frequent
blood tests in order to identify patients sensitive to the drug. 
In patients experiencing mild liver toxicity, it is often possible
to continue at a lower dose or stop and then resume therapy at a
lower dose.  Other side effects include nausea, vomiting, diarrhea
and rash. 
      Tacrine has been available since February l992 to patients
under a "treatment IND" protocol that has permitted more than 7,400
patients to receive the drug while the controlled clinical studies 
were being completed. IND stands for "investigational new drug."  
     FDA is one of eight Public Health Service agencies within HHS.
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