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News in Brief
APOKYNTM, a Rescue Drug for Treating "Off" Periods for use in Parkinson's Disease, is Approved in the United States
Beginning in July 2004, Parkinson's patients who suffer from unexpected or sudden wearing-off spells will have a new and effective treatment option: an injectable dopamine agonist, apomorphine hydrochloride, or APOKYN™ (Bertek Pharmaceuticals, Inc.).
This therapy, an injectable medication, will help patients rapidly reverse the sudden, disabling symptoms that can occur when anti-parkinson medications suddenly stop working. Apomorphine, which has been approved and used successfully in the United Kingdom and Canada for several years, treats these "off" periods when injected under the skin. In clinical trials, patients taking apomorphine during "off" periods showed marked improvement within minutes of the drug injection.
Apomorphine is meant for rapid, temporary relief of severe Parkinson's symptoms, and its effects last only about 30 minutes. In that interval, patients have enough time for their oral medications to resume working. Apomorphine is not intended for chronic use. PDF physicians advise that the new medication will be particularly useful for patients in the morning, before their regular medications have had the opportunity to take effect.
Although the FDA is asking for post-marketing studies, these studies will not delay a July launch date of the newly-released product. Patients and their caregivers need to be instructed by a physician on the proper use of apomorphine. The correct dose is determined by the treating neurologist and can be loaded into pre-calibrated syringes. Because of the nausea and vomiting that may accompany APOKYN™, patients must take a supplementary oral drug, trimethobenzamide. APOKYN™ may also cause low blood pressure and fainting.
Other possible side-effects include sleepiness, dyskinesias, dizziness, increased sweating and flushing-all symptoms that can occur with dopamine drugs.
For more information on APOKYN™, call the toll-free number (877) 7APOKYN or visit www.apokyn.com.
Pergolide (Permax) Linked to Heart Valve Disease
New data from a study published April 10, 2004, in The Lancet reveals that the use of pergolide (Permax) may be associated with a risk for developing heart valve disease.
In this study conducted in Belgium, 78 PD patients treated with pergolide and 18 untreated PD "controls" underwent an echocardiogram, which was read by an investigator blinded to treatment status. Evidence of restrictive valvular heart disease was detected in 26 patients (33 percent) in the pergolide-using group versus none among the controls. Fifteen of the 26 showed a serious level of heart valve disease. The data indicate that heart valve damage associated with the drug is not rare, as the scientific community had previously thought.
Pergolide, first marketed in the U.S. in 1989, is approved by the FDA for use as monotherapy or in combination with levodopa and carbidopa (Sinemet) in the management of Parkinson's disease. Pergolide is a derivative of a natural product known as ergot. The damage to heart valves is similar to damage detected with the use of other ergot products.
Dr. Stanley Fahn, H. Houston Merritt professor of neurology at Columbia Univer-sity, who serves also as PDF's scientific director, advises patients who are taking pergolide to contact their physician and request an echocardiogram to establish whether there is any evidence of heart damage. If evidence is present, your doctor may recommend that you change drugs to an alternative that is a non-ergot derivative to avoid possible further damage.
Rasagiline Shown to Ease Freezing Episodes in PD
Recent study results indicate that the drug rasagiline, a "MAO-B inhibitor", has potential as an effective therapy for Park-inson's disease in several areas.
The drug's manufacturer, Teva Pharm-aceuticals, released research findings showing that treatment with rasagiline significantly reduced freezing of gait (temporary and often unpredictable inability to move the feet and legs when stepping). The Parkinson Study Group (PSG) also published study findings in the April 2004 issue of Archives of Neurology, reporting that people who took once-daily, one or two mg doses of rasagiline for 12 months showed less impairment than those who received active treatment for only six months.
The double-blind PSG study divided 371 participants into three groups: one treated with rasagiline in two mg daily doses for 12 months; another treated with a daily one mg dose; and a third with "delayed treatment" beginning with placebo for six months and then two mg doses for six months.
People in the first two groups demonstrated a slower rate of impairment, as measured by the Unified Parkinson's Disease Rating Scale, a research tool that measures performance of mental and motor tasks and daily living activities. These findings are consistent with the freezing of gait study that also indicated motor symptom relief.
Confirmation of rasagiline's potential role in neuroprotection (that is, in slowing the progression of Parkinson's) will require long-term studies, experts say. Pending FDA approval, Teva expects to market rasagiline as an adjunct or monotherapy in late 2004.
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