FDA Approves Boehringer Ingelheim's Pramipexole for the Treatment of Moderate-to-Severe Primary Restless Legs Syndrome (RLS)

Ingelheim, Germany, November 10 (ots/PRNewswire) -

- Millions of People Worldwide Living With RLS to Benefit as
Treatment Becomes Globally Available

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(R) / Sifrol(R) / Mirapex(R)), 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 years(5) and around one-third of sufferers
experience symptoms more than twice weekly causing moderate to severe
distress(2). 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(R)
and Sifrol(R) and in the U.S.A. as Mirapex(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 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 www.boehringer-ingelheim.com

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.

INGELHEIM, Germany, November 10 /PRNewswire/ --

References

1. Mirapex(R) 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.

ots Originaltext: Boehringer Ingelheim
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contact: Ursula Bardon, Corporate Division Communications, Boehringer
Ingelheim GmbH, 55216 Ingelheim/Germany, Phone: +49-6132-77-2622,
Fax: +49-6132-72-2622