- Salix's NDA for crofelemer in HIV-associated diarrhea assigned priority review status
- Genentech's BLA for pertuzumab receives priority review status in previously untreated HER2-positive metastatic breast cancer indication
- FDA reviewers questions efficacy of NeurogesX's Qutenza pain patch in proposed new use
- Shire's Vyvanse approved for maintenance treatment in adults with ADHD
- FDA accepts Ziopharm's IND application for oral formulation of Zymafos
- Private FFS MA plans may be linked with higher costs for beneficiaries, GAO report shows
- Pediatric subspecialty telephone consultations may be cost-saving for Medicaid, research reveals
- Use of mental health services greater in health plans with parity in cost sharing, data find
- Public opinions appear split on health care affordability, satisfaction, survey finds
- In Brief: California Supreme Court
FDA approves extended-release formulation of pramipexole for treatment of early PD
Wednesday, March 03 2010 | Comments
What's This?
The Food and Drug Administration approved pramipexole dihydrochloride extended-release (ER) tablets as a once-daily treatment for the signs and symptoms of early idiopathic Parkinson's disease (PD).The approval of pramipexole ER was supported by clinical pharmacokinetic data and by a clinical trial program consisting of 2 studies. The clinical program included >400 patients with early PD who were treated with varying doses of pramipexole ER, the immediate-release formulation (which is already approved and is taken 3 times daily), or placebo.
The first study compared pramipexole ER and pramipexole, each against placebo. Relative to the placebo-treated patients, those treated with pramipexole ER experienced clinically significant symptom relief, as measured by a mean change from baseline in the Unified Parkinson's Disease Rating Scale II+III score, after 18 weeks of treatment. The pramipexole-treated patients experienced similar clinically significant improvements as compared with placebo.
In a second study conducted during a 9-week period, researchers evaluated the efficacy of an overnight switch from pramipexole to pramipexole ER. Boehringer Ingelheim Pharmaceuticals Inc., who will market the new formulation under the brand name Mirapex ER, said 85% (87 of 104) of the patients who completed the trial were successfully switched to pramipexole ER, although some patients required dose adjustments.
In both studies, the safety and tolerability profile of pramipexole ER in patients with early PD was similar to that of pramipexole when each was compared with placebo.
Boehringer Ingelheim noted that pramipexole ER is not indicated for patients with advanced PD or for the treatment of restless legs syndrome.
Comments
Be the first to write a comment for this article!
You must be logged in to post a comment.
- White blood cell count in presence of elevated ESR, CRP level predicts infection status in patients undergoing total hip arthroplasty, researchers report
- AISRS useful in measuring methylphenidate therapy for adults with ADHD
- Adalimumab improves peripheral arthritis, enthesitis, axial signs, symptoms of AS in patients with long-standing disease treated in real-life practice, researchers report
- Symptoms of early, delayed puberty demand close clinical attention, in spite of shifting norms for pubertal onset
- Low-dose doxepin improves wake after sleep onset among individuals with primary insomnia, data indicate
- School-based nutrition, exercise intervention program may not maintain BMI decreases through 10 months in overweight students, data indicate
- Careful discharge planning, follow-up vital for high-risk neonates facing hospital discharge, updated AAP guidelines state
- Nissen fundoplication in children with GERD reduces need for antireflux medication, researchers find
- AISRS useful in measuring methylphenidate therapy for adults with ADHD
- Radiotherapy, chemotherapy increase risks of second malignancy, cardiovascular disease similar to smoking in patients with testicular cancer, researchers report
