For medical media, outside the US only
Ingelheim/Germany, 26 June 2009 - 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/ Sifrol (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 / Sifrol 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 with the convenience of a single daily dose. The once daily administration of the new Mirapexin 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 may be switched overnight from the immediate release tablets to the Mirapexin prolonged-release tablets, at the same daily dose.5 In addition to benefiting from the high therapeutic value of Mirapexin,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 / Sifrol is currently registered as immediate release formulation only.)
A new drug application (NDA) for a once daily, extended release formulation of Mirapex 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 PD 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 overtime.
About Mirapexin/Sifrol (pramipexole)
Pramipexole (known under the trade names Mirapexin, Sifrol, Mirapex and Pexola) 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 globe.
The most commonly (≥ 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 veterinary medicine.
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.
|page||Parkinson's Disease: Efficacy and safety of a once daily Mirapexin|
|page||Parkinson's Disease: European approval for new strengths for Mirapexin®/Sifrol®|
|page||Parkinson's Disease: Mirapexin for Parkinson's Disease treatment|
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 2009).
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.