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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.