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New Data on Once-Daily Extended Release Pramipexole Presented at 13th International Congress of Parkinson's Disease and Movement Disorders (MDS).

Data indicates pramipexole extended release is comparable to the immediate release formulation

PARIS -- New data presented today at the Movement Disorder Society's 13th International Congress of Parkinson's Disease and Movement Disorders (MDS) suggest that pramipexole once-daily, extended release (ER) formulation is comparable to pramipexole immediate release (IR) formulation in patients with advanced Parkinson's disease (PD). These data support the results from a previous trialthat assessed the efficacy, safety and tolerability of the once-daily ER formulation in the treatment of early PD after 18 weeks, and non-inferiority between pramipexole ER and pramipexole IR after 33 weeks, as presented for the first time today at the MDS.

The randomized, placebo-controlled trial assessed the efficacy and safety of a once-daily, ER formulation of pramipexole - administered as adjunctive therapy in advanced PD - compared to its IR formulation when administered under the same therapeutic conditions. Both the primary and the key secondary endpoints were met in the study as measured by the change from baseline in UPDRS* II+III and percentage of off-time, the period of reduced motor functioning at the end of the dosing interval, during waking hours.

"These findings support pramipexole extended release formulation as a potential new once-daily treatment option for people with Parkinson's disease," said Robert Hauser, MD, Professor of Neurology, and Director, Parkinson's Disease & Movement Disorders Center at the University of South Florida College of Medicine, and a co-author on the studies.

About the Studies

A randomized, placebo-controlled, double-blind trial comparing pramipexole extended release (ER) and immediate release (IR) formulations versus placebo, as adjunctive therapy, after 18 weeks of treatment, in patients with advanced PD:

* A total of 507 patients were included in the efficacy analyses at week 18.

* In these patients, the adjusted mean change in UPDRS II+III score from baseline to week 18 was -6.1 points for placebo, -11.0 points for extended release (p=0.0001 vs. placebo) and -12.8 points for immediate release (p<0.0001 vs. placebo).

* The adjusted mean change in percentage off-time was -8.8 points for placebo, -13.3 points for extended release (corresponding to an improvement of -2.1 hours from baseline; p=0.0199 vs. placebo) and -15.9 for immediate release (corresponding to an improvement of -2.5 hours from baseline p<0.0001 vs. placebo).

* Adverse event rates were similar for pramipexole ER (54.9%) compared to placebo (55.6%) and numerically lower than pramipexole IR (64.0%).

A randomized, placebo-controlled, double-blind trial comparing pramipexole extended release (ER) and immediate release (IR) formulations versus placebo after 18 weeks and 33 weeks of treatment, in patients with early PD:

* A total of 253 patients were included in the 18-week analysis testing for superiority of pramipexole extended release versus placebo.

* In these patients, the adjusted mean change in the UPDRS II+III score from baseline to week 18 was -5.1 points in the placebo group, -8.1 points in the pramipexole extended release group (p=0.0282 vs. placebo), and -8.4 points in pramipexole immediate release group (p=0.0153 vs. placebo).

* A sub-group of 84 patients had completed 33 weeks of treatment at the first analysis cut-off and were included in the descriptive analysis of maintenance of efficacy. The UPDRS II+III score was almost unchanged from week 18 to week 33 in both pramipexole groups, while a worsening was observed in placebo patients. In the pramipexole extended release group, the adjusted mean change from baseline in the UPDRS II+III score was -11.5 points at week 33 versus -11.8 points at week 18, a difference of +0.3 point (or 2.5%). For the pramipexole immediate release group, both changes (week 33 and week 18) were -11.9 points, a difference of 0 percent. For the placebo group, the mean change was -2.7 points at week 33 versus -4.2 points at week 18, a worsening of +1.5 points (or 35.7%).

* Non-inferiority between pramipexole extended release and pramipexole immediate release was assessed at week 33. The adjusted mean change in the UPDRS II+III score from baseline to week 33 were -8.6 points in the pramipexole extended release group (n= 213) and -8.8 points in the pramipexole immediate release group (n= 207), a between-group difference of -0.2 point, 95% CI=[-2.2, +1.7]. The lower bound of the 95% CI (-2.2 points) was higher than the pre-defined non-inferiority margin of -3 points, demonstrating non-inferiority between pramipexole extended release and pramipexole immediate release at week 33.

*The Unified Parkinson's Disease Rating Scale (UPDRS)

The Unified Parkinson's Disease Rating Scale (UPDRS) is a comprehensive tool, which was developed to follow the longitudinal course of PD-related disability and impairment. The UPDRS II+III score was used as the primary efficacy endpoint in both trials. UPDRS Part II relates to activities of daily living and UPDRS Part III relates to motor symptoms. The UPDRS II+III score ranges from 0 (no disability) to 160 (worst disability).

About Parkinson's disease

Parkinson's disease is a progressive neurological disorder that affects nearly one million people in the U.S. It is the second most common chronic neurological disorder in older adults after Alzheimer's. Every nine minutes someone is diagnosed with Parkinson's disease. Symptoms include tremor, muscle rigidity, slowed motion, shuffling gait, and a loss of facial expression. The symptoms vary from individual to individual, but become more severe over time. Although promising research is being conducted, there is currently no cure for Parkinson's disease.

About pramipexole

Pramipexole dihydrochloride tablets, in an immediate release formulation, are indicated in the U.S. for the treatment of the signs and symptoms of idiopathic Parkinson's disease (PD) and for moderate-to-severe primary restless legs syndrome (RLS). Pramipexole is supported by more than a decade of real-world experience in the treatment of Parkinson's disease, with more than 10 million prescriptions written in the U.S. since its launch in 1997.

Patients have reported falling asleep without perceived warning signs during activities of daily living, including operation of a motor vehicle, which sometimes resulted in accidents. Hallucinations and postural (orthostatic) hypotension may occur. In clinical trials for early PD using immediate release tablets, the most commonly reported side effects of pramipexole that were more frequent than with placebo are nausea (28% vs. 18%), dizziness (25% vs. 24%), somnolence (22% vs. 9%), insomnia (17% vs. 12%), asthenia (14% vs. 12%), and constipation (14% vs. 6%). In clinical trials for advanced PD, the most commonly reported side effects of pramipexole that were more frequent than with placebo are postural hypotension (53% vs. 48%), dyskinesia (47% vs. 31%), extrapyramidal syndrome (28% vs. 26%), insomnia (27% vs. 22%), dizziness (26% vs. 25%), accidental injury (17% vs. 15%), hallucinations (17% vs. 4%), and dream abnormalities (11% vs. 10%). In clinical trials for RLS, the most commonly reported side effects of pramipexole that were more frequent than with placebo are nausea (16% vs. 5%), headache (16% vs. 15%), fatigue (9% vs. 7%) and somnolence (6% vs. 3%).

Patients and caregivers should be informed that impulse control disorders and compulsive behaviors have been reported in patients taking dopamine agonists, including pramipexole.

A once-daily, extended release formulation of pramipexole dihydrochloride tablets is currently under review by the U.S. Food and Drug Administration for the treatment of the signs and symptoms of idiopathic Parkinson's disease.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

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 approximately 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 U.S. $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.
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