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New Parkinson's Disease Drug Requip From SmithKline Beecham Cleared for Use
By FDA
New dopamine agonist may change the way physicians treat early Parkinson's
disease
Philadelphia, PA, September 22, 1997 -- SmithKline Beecham's Requip
(ropinirole hydrochloride) received marketing clearance today from the U.S.
Food and Drug Administration (FDA) for treatment of the signs and symptoms of
Parkinson's disease, both as initial therapy and as adjunctive treatment with
levodopa. Unlike older dopamine agonists, Requip, which is a second
generation dopamine agonist, is licensed for use in patients with early
Parkinson's disease (without levodopa) and in patients with advanced
Parkinson's disease (with levodopa).
Currently, the standard treatment for Parkinson's disease is levodopa.
Levodopa is very effective initially, but over time patients will need to
increase their dosage to maintain control of symptoms.
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 highly selective second-generation dopamine agonist
that works by mimicking the effects of dopamine.
Efficacy in Early Parkinson's Disease
The effects of Requip as initial therapy in patients with mild to moderate
Parkinson's disease were assessed in a double-blind, randomized,
placebo-controlled study. Results were obtained through a measurement used
by physicians to assess the disease status of Parkinson's disease patients
called the Unified Parkinson's Disease Rating Scale (UPDRS). Physicians
measured the overall change they saw in their patients' motor function.
Patients treated with Requip (n=116) demonstrated a significantly superior
improvement in motor score of 24 percent compared to placebo-treated patients
(n=125) who demonstrated a three percent worsening in motor score after six
months. In addition, 33 percent of patients treated with Requip were rated
as either "much improved" or "very much improved" on the Clinical Global
Impressions (CGI) improvement item compared to 12 percent of patients given
placebo.
Efficacy as Adjunctive Therapy With Levodopa
The efficacy of Requip as adjunctive therapy with levodopa in the late stages
of Parkinson's disease was confirmed in a double-blind, randomized study
comparing patients treated with Requip (n=94) to patients treated with
placebo (n=54). Investigators evaluated the number of "responders," defined
as patients who were able to achieve: (1) a decrease (compared to baseline)
of at least 20 percent in their levodopa dose, and (2) a decrease of at least
20 percent in the proportion of time awake in the "off" condition (period of
time during the day when patients are particularly immobile).
After six months, 28 percent of patients treated with Requip were classified
as responders versus 11 percent of placebo-treated patients. This difference
was statistically significant. In addition, 49 percent of Requip-treated
patients had their levodopa dose reduced by at least 20 percent versus 17
percent of placebo-treated patients. This difference was also statistically
significant. The average levodopa dose reduction was 31 percent for patients
treated with Requip. This study demonstrates that the adjunctive use of
Requip with levodopa allows for the reduction of a patient's levodopa dose,
therefore reducing the total amount of levodopa which must be taken daily.
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, and hallucinations can occur at any time during the
course of treatment.
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