Boehringer Ingelheim
announced today that the U.S. Food and Drug Administration (FDA) has
approved pramipexole, a non-ergot dopamine agonist, for the treatment of
moderate to severe primary Restless Legs Syndrome (RLS).1 This is an
important milestone for pramipexole (Mirapexin® / Sifrol® / Mirapex®),
which was already approved throughout the European Union in April 2006
for this second indication.
Millions of patients worldwide are affected by RLS, a debilitating
neurological condition. Restless Legs Syndrome is characterised by a
compelling urge to move the legs, usually associated with uncomfortable or
sometimes painful sensations in the legs, with symptoms being worse at
night and while at rest.2 Restless Legs Syndrome patients may also
experience daytime tiredness, mood disturbance, and inability to perform
daily activities, such as travelling long distances or going to the cinema.2,3,6
"Often patients don't realise that they have an underlying treatable medical
condition that is causing these symptoms as well as sleep disturbance. With
pramipexole, physicians now have another option to help manage their
patients' RLS symptoms," said Professor John W. Winkelman, MD, PhD,
Medical Director of the Sleep Health Center of Brigham and Women's
Hospital, Boston, Massachusetts, USA.
The FDA approval was based on safety and efficacy data from four
randomised, double-blind, placebo-controlled clinical trials. These studies
involved approximately 1,000 patients with primary moderate-to-severe
RLS who were administered pramipexole (0.125mg, 0.25mg, 0.5mg and
0.75mg) or placebo once daily, 2-3 hours before going to bed. In clinical studies, patients treated with pramipexole experienced statistically and
clinically significant improvements in short- and long-term efficacy versus
placebo. In three clinical studies, the mean change from baseline in total
International RLS Rating (IRLS) scores for patients treated with
pramipexole demonstrated a statistically significant greater improvement
compared with placebo-treated patients. In a fourth study, efficacy was
sustained with pramipexole over a period of nine months, including a six-
month open label treatment period followed by a 12-week placebo-
controlled withdrawal period. 1,4
"Building on nearly a decade of worldwide experience for pramipexole in
the treatment of Parkinson's Disease, we are pleased that the FDA has also
approved this second indication. Pramipexole will now be available to the
millions of people across the globe living with RLS, helping them to enjoy a
better quality of life," said Dr. Andreas Barner, Vice Chairman of the Board
of Managing Directors and responsible for the Corporate Board Division
Pharmaceutical Research, Development and Medicine at Boehringer
Ingelheim.
About Restless Legs Syndrome (RLS)
Restless Legs Syndrome is a neurological disorder characterised by an
uncontrollable urge to move the legs, usually accompanied by unpleasant
and sometimes painful sensations in the legs. Restless Legs Syndrome
affects up to ten percent of the population worldwide aged between 30 and
79 years5 and around one-third of sufferers experience symptoms more than
twice weekly causing moderate to severe distress2. The motor-restlessness
worsens during the evening and night causing difficulty initiating and
maintaining sleep. The sleep disruption can lead to excessive daytime
sleepiness and compromise work performance. Restless Legs Syndrome
also has considerable impact on social activities that require immobility.
Despite many years of research and increased disease recognition, RLS still
remains underdiagnosed or misdiagnosed to this day. RLS may be
diagnosed with positive answers to the following criteria, which were
developed by participants in the RLS Diagnosis & Epidemiology workshop
at the National Institutes of Health in collaboration with members of the
International Restless Legs Syndrome Study Group (IRLSSG)7:
-- Do you have an urge to move your legs, usually accompanied by
uncomfortable leg sensations?7
-- Do your symptoms begin or worsen during rest or inactivity, such as
lying down or sitting?7
-- Are your RLS symptoms partially or totally relieved by movement,
such as walking or stretching?7
-- Are your RLS symptoms worse in the evening or at night, or do they
only occur in the evening and at night?7
About pramipexole
Pramipexole (known in Europe under the trade names Mirapexin® and
Sifrol® and in the U.S.A. as Mirapex®) 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 April 2006 throughout the European Union
for the symptomatic treatment of moderate to severe idiopathic Restless
Legs Syndrome (RLS), in addition to other countries such as Australia,
Brazil, Canada, Mexico, U.S.A. and others.
The most commonly reported adverse reactions in early and late Parkinson's
disease in clinical trials were dizziness, involuntary movement, postural
hypotension, constipation, hallucinations, headache, difficulty falling asleep,
sleepiness, nausea and fatigue. The most commonly reported adverse
reactions in clinical trials for Restless Legs Syndrome were nausea,
headache, and tiredness.
Pramipexole may cause patients to fall asleep without any warning, even
while doing normal daily activities such as driving. When taking
pramipexole hallucinations may occur and sometimes patients may feel
dizzy, sweaty or nauseated upon standing up. It should be noted that
impulse control disorders/compulsive behaviours may occur while taking
medicines to treat Parkinson's disease, including pramipexole.
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it
operates globally with 143 affiliates in 47 countries and almost
37,500 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 2005, Boehringer Ingelheim posted net sales of 9.5 billion euro while
spending almost one fifth of net sales in its largest business segment
Prescription Medicines on research and development.
For more information please visit boehringer-ingelheim
Disclaimer: Press Release for international use. As to the registration status
in individual countries, please check with the contact address indicated
below or liaise with the country-specific Boehringer Ingelheim affiliate.
References
1. Mirapex® prescribing information
2.Allen RP, Walters AS, Montplaisir J, Hening W, Myers A, Bell TJ, et al. Restless Legs
Syndrome prevalence and impact: REST general population study. Arch Intern Med 2005;
165: 1286-1292
3. Earley CJ. Clinical practice: Restless legs syndrome. New Engl J Med 2003: 348(21);
2103-2109
4. Data on file, Boehringer Ingelheim
5. Phillips B et al. Epidemiology of restless legs symptoms in adults. Arch Intern Med
2000; 160(14): 2137-2141
6. National Heart, Lung and Blood Institute Working Group on Restless Legs Syndrome.
Restless legs syndrome: detection and management in primary care. Am Fam Physician
2000;62:108-114.
7. Allen RP, Picchietti D, Hening WA, et al. Restless legs syndrome: diagnostic criteria,
special considerations, and epidemiology. A report from the restless legs syndrome
diagnosis and epidemiology workshop at the National Institutes of Health. Sleep Med
2003;4:101-119.
View drug information on Mirapex; Pramipexole.