SmithKline Beecham Parkinson’s Disease Press Release – 10/14/97
New Parkinson’s Disease Drug Requip Now Available From SmithKline Beecham
Philadelphia, PA, October 14, 1997 — SmithKline Beecham (NYSE:SBH) today
announced nationwide availability of Requip (ropinirole hydrochloride), a
new, second-generation dopamine agonist indicated for the treatment of the
signs and symptoms of Parkinson’s disease, both as initial therapy (without
levodopa) and as adjunctive treatment with levodopa. Unlike older ergot
dopamine agonists, Requip is licensed for use in patients with early
Parkinson’s disease (without levodopa) and in patients with advanced
Parkinson’s disease (with levodopa). Requip received marketing clearance
from the U.S. Food and Drug Administration in late September.
Requip is a non-ergot dopamine agonist that works by mimicking the effects of
dopamine. Clinical studies showed that Requip effectively controls the
debilitating motor symptoms associated with Parkinson’s disease such as
tremor, muscle stiffness and impaired balance in both early and late stage
disease.
In both early and adjunct therapy studies, Requip was generally well
tolerated. In the early therapy study, the most common adverse experience
was nausea, which was related to the stimulation of dopamine receptors. Other
adverse experiences that occurred less frequently included dizziness,
somnolence and headaches. In the adjunctive therapy study, in patients
already experiencing motor fluctuations, the most common adverse experience
was dyskinesia. Other adverse experiences that occurred less frequently
included nausea, dizziness, and somnolence. All Parkinson’s patients should
be informed that syncope or symptomatic hypotension may occur more frequently
during initial treatment or with an increase in dose. Hallucinations can
occur at any time during the course of treatment.
Requip is available in five tablet strengths: 0.25 mg, 0.5 mg, 1 mg, 2 mg,
and 5 mg, and its wholesale acquisition cost (WAC) is significantly less than
older, first generation, ergoline dopamine agonists. Pharmacies wishing to
order Requip can call SmithKline Beecham’s Customer Satisfaction department
at 1-800-366-8900.
A Progressive Neurodegenerative Disorder
Parkinson’s disease, which affects between 500,000 and 1,000,000 Americans,
is a chronic and progressive disorder which results from the death of nerve
cells in a critical area of the brain called the substantia nigra. These
nerve cells normally produce dopamine, a chemical messenger that plays an
important role in motor movement control by transmitting signals between
the substantia nigra and another critical area of the brain called the
striatum. Dopamine depletion results in a patient’s impaired ability to
control motor movements. Requip is a second-generation dopamine agonist that
works by mimicking the effects of dopamine.