Ingelheim, Germany (ots/PRNewswire) -
- For non-U.S. Healthcare Media
Boehringer Ingelheim announced today that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMEA) has issued a positive opinion recommending the approval
of a once daily formulation for Mirapexin(R) / Sifrol(R)
(pramipexole), in all countries of the European Union, Norway,
Iceland and Liechtenstein. The CHMP recommendation states that the
new prolonged-release formulation is indicated for treatment of the
signs and symptoms of idiopathic Parkinson's disease, alone (without
levodopa) or in combination with levodopa, i.e. over the course of
the disease, through to late stages when the effect of levodopa wears
off or becomes inconsistent and fluctuations of the therapeutic
effect occur (end of dose or "on off" fluctuations).
The CHMP recommendation follows clinical trial results confirming
the high therapeutic benefits of Mirapexin(R) / Sifrol(R) also when
administered in a convenient once-a-day formulation.(1-4)
"We are very pleased about the positive recommendation. This
effective new treatment option combines the trusted clinical benefits
of Mirapexin(R) with the convenience of a single daily dose. The once
daily administration of the new Mirapexin(R) prolonged-release
formulation has been shown to cause less frequent fluctuations in the
pramipexole plasma concentration over 24 hours compared to the three
times daily administration of pramipexole immediate release tablets.
Once approved, PD patients already taking Mirapexin(R) may be
switched overnight from the immediate release tablets to the
Mirapexin(R) prolonged-release tablets, at the same daily dose.(5) In
addition to benefiting from the high therapeutic value of
Mirapexin(R), the reduced pill burden will mean added convenience for
patients and their carers. It is important for physicians to have
effective and flexible treatment regimens to choose from so that they
can offer individualised treatments in line with the patient's
needs," commented Dr. Manfred Haehl, MD, Senior Vice-President
Medicine at Boehringer Ingelheim Corporate Headquarters.
(Note: Mirapexin(R) / Sifrol(R) is currently registered as
immediate release formulation only.)
A new drug application (NDA) for a once daily, extended release
formulation of Mirapex(R) is in review with the U.S. Food and Drug
Administration (FDA) for the treatment of Parkinson's disease
(currently available in the U.S.A. as immediate release formulation).
Boehringer Ingelheim is looking forward to making the new formulation
available to patients with Parkinson's disease in the U.S.A. should
the FDA approve the filed submission.
Notes to Editor:
Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters
in Germany. Please be aware that there may be national differences
between countries regarding specific medical information, including
licensed uses. Please take account of this when referring to the
information provided in this document. This press release is not
intended for distribution within the U.S.A.
About Parkinson's disease (PD)
Parkinson's disease is the second most common chronic
neurological Disorder in older adults after Alzheimer's. Its
worldwide prevalence is estimated to be approximately one to two
percent of those over 65 years. (6-8) Although traditionally PD is
associated with motor symptoms (such as tremor, rigidity, slowed
motion, imbalance, shuffling gait, loss of facial expression), the
non-motor symptoms, including depressive symptoms, pain, cognitive
impairment and sleep disorders can be significant. Symptoms can vary
from patient to patient, but worsen over time.
About Mirapexin(R)/Sifrol(R) (pramipexole)
Pramipexole (known under the trade names Mirapexin(R), Sifrol(R),
Mirapex(R) and Pexola(R)) is a compound from Boehringer Ingelheim
research first approved in 1997 for the treatment of the signs and
symptoms of idiopathic Parkinson's disease, as monotherapy or in
combination with levodopa. Pramipexole was approved in 2006 for the
symptomatic treatment of moderate to severe idiopathic Restless Legs
Syndrome (RLS). Pramipexole is available in over 70 countries across
The most commonly (greater than or equal to 5%) reported adverse
drug reactions in patients with Parkinson's disease treated with
pramipexole were nausea, dyskinesia, hypotension, dizziness,
somnolence, insomnia, constipation, hallucination, headache and
fatigue. Pramipexole may cause patients, particularly with
Parkinson's disease, to fall asleep without any warning even while
doing normal daily activities such as driving. When taking
pramipexole hallucinations can occur and sometimes patients may feel
dizzy, sweaty or nauseated upon standing up.
Patients and caregivers should be aware of the fact that abnormal
behaviour (reflecting symptoms of impulse control disorders and
compulsive behaviours) such as binge eating, compulsive shopping,
hypersexuality and pathological gambling have been reported in
patients treated with dopaminergic drugs, including pramipexole. Dose
reduction/tapered discontinuation should be considered.
The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it
operates globally with 138 affiliates in 47 countries and 41,300
employees. Since it was founded in 1885, the family-owned company has
been committed to researching, developing, manufacturing and
marketing novel products of high therapeutic value for human and
In 2008, Boehringer Ingelheim posted net sales of 11.6 billion
euro while spending one fifth of net sales in its largest business
segment Prescription Medicines on research and development.
For more information please visit
Further information on Parkinson's disease and pramipexole can be
found at http://www.PDKnowledgeGuide.com.
1. Hauser R et al. Double-blind evaluation of pramipexole
extended-release (ER) in early Parkinson's disease. Abstract S43.003
presented on 30 April 2009 at 61st Annual Meeting, Seattle, USA.
2. Salin L et al. Double-blind evaluation of maintenance of
efficacy of pramipexole extended-release in early Parkinson's
disease. Abstract P06.150 presented on 29 April 2009 at AAN 61st
Annual Meeting, Seattle, USA.
3. Poewe, W et al. Pramipexole Extended-Release is Effective in
Early Parkinson's Disease. Poster We-185. (presented at MDS
International Congress, Paris, France, 10 June 2009).
4. Schapira, A et al. Efficacy and safety of pramipexole
extended-release for advanced Parkinson's disease. Poster We-199
(presented at MDS International Congress, Paris, France, 09 June
5. Rascol O et al. Overnight switching from immediate- to
extended-release pramipexole in early Parkinson's disease. Abstract
P06.152 presented on 29 April 2009 at AAN 61st Annual Meeting,
Seattle, USA, 30 April - 02 May 2009.
6. Nussbaum R et al. Alzheimer's disease and Parkinson's disease.
N Engl J Med 2003;348:1356-64.
7. de Rijk MC et al. Prevalence of Parkinsonism and Parkinson's
disease in Europe: the EUROPARKINSON Collaborative Study. European
Community Concerted Action on the Epidemiology of Parkinson's
disease. J Neurol Neurosurg Psychiatry. 1997;62:10-5.
8. Parkinson Study Group, Holloway RG et al. Pramipexole vs
levodopa as initial treatment for Parkinson disease. Arch Neurol
2004; 61(7): 1044-1053.
ots Originaltext: Boehringer Ingelheim
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Contact: Ursula Bardon, Corporate Division Communications, Boehringer
Ingelheim GmbH, 55216 Ingelheim/Germany, Phone: +49-6132-77 2622,
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