ANSWERS
08/18/1995

<TITLE>FDA APPROVES NEW DRUG THERAPY FOR OSTEOPOROSIS</TITLE>
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T95-43                                           Arthur Whitmore
Aug. 18, 1995                                    301-443-3285


         FDA APPROVES NEW DRUG THERAPY FOR OSTEOPOROSIS

     We are receiving inquiries about the approval of calcitonin
salmon nasal spray for the treatment of osteoporosis.  The drug is
approved for use by postmenopausal women, beginning five years
after menopause.  The following can be used to respond to
questions.
     Osteoporosis -- the thinning of bones in postmenopausal women
and elderly men -- is a major cause of bone fractures affecting as
many as 20 million Americans.  Women over age 45 commonly suffer
fractures of the hip, wrist or spine due to loss of bone mass from
osteoporosis.   
     Until today's approval of calcitonin salmon nasal spray, only
injectable calcitonin salmon and estrogen (considered first-line
treatment) have been approved to treat or prevent osteoporosis.  
    Two randomized clinical trials demonstrated that daily use of
calcitonin nasal spray increases bone mass in the spine.  However,
no bone-building effects were shown on bone mass of the forearm or
hip.  The manufacturer has agreed to conduct additional studies to
evaluate the product's long-term effectiveness in preventing
fractures.
                             -more-

                           T95-43, Page 2, Calcitonin salmon
     Patients using the nasal spray should have periodic nasal
examinations for ulceration or irritation.  The most common adverse 
events reported during clinical trials included rhinitis
(inflammation of the membranes in the nose), nosebleeds and
sinusitis (inflammation of the sinus cavity).
     In November l994, FDA's Endocrinologic and Metabolic Advisory
Committee recommended approval of calcitonin nasal spray if coupled
with a commitment by the manufacturer to study the long-term
efficacy of the nasal spray on fracture rates.   
      FDA emphasizes that women on drug therapy for osteoporosis
should take daily supplements of calcium and vitamin D.  This
regimen -- along with exercise -- has been shown to help prevent
the loss of bone mass.    
     Calcitonin salmon nasal spray is manufactured by Sandoz
Pharmaceuticals Corp. of East Hanover, N.J., and will be marketed
under the trade name Miacalcin Nasal Spray. 
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