News
10/25/1988

<TITLE>Sandostatin Approval</TITLE>
<PRE>
Sandostatin Approval

P88-32                                      Food and Drug Administration
FOR IMMEDIATE RELEASE                       Faye Peterson & Brad Stone
October 25, 1988                            (301) 443-3285 (Office) 

    The Food and Drug Administration today announced approval of a drug that
treats a type of chronic and severe diarrhea more immediately 
life-threatening than the slow-growing intestinal cancers that cause it.
    Even when these cancers -- malignant carcinoid tumors and vasoactive
intestinal peptide-secreting tumors -- are found too late to be operable, 
patients can live up to l5 to 20 years before succumbing to the cancer
itself.  But the diarrhea and associated weight loss can weaken them to such
a degree that they are confined to wheelchairs, unable to perform the 
smallest tasks for themselves.
    FDA Commissioner Frank E. Young, M.D., Ph.D., said that in arresting the
dangerous diarrhea, "this drug can dramatically improve life for these
cancer patients, permitting many to pursue their normal lives for years,
rather than be weakened and continually hospitalized."  The new drug is 
called octreotide acetate.
    Dr. Young said, "For many, it will reduce or eliminate the frequent and 
devastating bouts of diarrhea that often require repeated hospitalizations
for intravenous fluid replacement therapy." 
    The drug does not cure the tumors themselves, which occur with symptoms 
in approximately one or two people per million annually in the United 
States.  These slow-growing cancers may go undetected for as long as seven
or eight years, by which time they may have spread to the liver and be
inoperable. 
    While patients can still live for years, the tumors cause excessive 
secretions of peptides that trigger severe and unrelenting diarrhea.  This
is accompanied, in some cases, by wheezing, facial flushing, or pronounced
loss of energy. 
    The new drug will be marketed as Sandostatin by Sandoz Pharmaceuticals
of East Hanover, N.J.  It mimics the action of somatostatin, a naturally
occurring hormone.  Found in the brain and gastrointestinal tract, the
hormone is one of several substances that regulate the release of secretions
by the body's organs.  Like the natural substance, Sandostatin inhibits 
excess release of the damaging intestinal tumor cell secretions, thus 
eliminating the source and cause of severe diarrhea.
    Since the drug is injected under the skin, patients generally will be 
taught to give their own injections, much as diabetic patients are taught to
give themselves insulin.
    The drug was first synthesized in l980 in the research labs of Sandoz 
Ltd. in Basel, Switzerland.  Major clinical trials have been conducted in 
the United States at the Mayo Clinic, Ohio State University and Oregon
Health Sciences University in Portland. 
    About three out of four patients in the trials responded promptly to
treatment with the drug.  Since long-term treatment led in a few cases to 
development of gallstones, ultrasonic monitoring of patients taking 
Sandostatin is recommended. 
</PRE>