Print

Print


I bring you all some good news from Kalamazoo Michigan.
 
"Pharmacia & Upjohn released to the media 1/4/96 that it has submitted a New
Drug Application (NDA) to the U. S. Food and Drug Administration for the
antiparkinsonian drug pramipexole.  Pramipexole was discovered by Boehringer
Ingelheim and co-developed with Pharmacia and Upjohn.  A member of a class of
drugs called dopamine agonists, pramipexole mimics the effects of dopamine --
the neurotransmitter whose decline and absence leads to PD.
 
P & U is seeking approval for pramipexole for the treatment of the signs and
symptoms of PD.  Currently available dopamine agonists are indicated for
adjunctive treatment with the drug levodopa and used predominantly in later
stages of the disease.
 
Preclinical research suggest pramipexole has three features which
differentiate it from currently available dopamine agonists:  it binds more
slecectively to dopamine receptors;  it preferentially binds to a dopamine
receptor called the D3 receptor;  and it is a full dopamine agonist.
 Currently available dopamine agonists only partially stimulate dopamine
receptors.
 
The NDA submission is based on three large phase III trials -- two trials as
monotherapy in early PD and one trial as combination (with levopa) therapy in
advanced PD.  The company plans to file additional registration documents
with health authorities worldwide in the coming weeks."
 
Jim Ryan - [log in to unmask]
56-7