Impax Labs sees success with Parkinson’s Drug
In a press release from March 2011 Impax Pharmaceuticals announced positive results of IPX066 in a Phase III clinical study testing the drug’s efficacy and safety. The study showed that IPX066 improved motor control symptoms for a longer amount of time in patients with advanced Parkinson’s disease. In the clinical trial IPX066 was compared to immediate-release carbidopa-levodopa, which is the gold standard of treatment for advanced cases.
Parkinson's Disease is a chronic neurodegenerative disorder that affects millions of people around the world. One of the major symptoms is loss of muscle control that leads to trembling of the arms and hands. IPX066 was developed to help control this trembling so that sufferers can function throughout the day. Some in the medical field believe that there is an unmet need amongst patients with advanced Parkinson’s disease to remedy this symptom and greatly improve their overall quality of life.
The main result that was looked at in the clinical trial was the “off time” afforded by the use of IPX066. In the case of patients with Parkinson’s disease, off-time refers to the time when the medication wears off and the symptoms of Parkinson’s return.
There were 471 participants in the clinical trial. Participants taking IPX066 experienced some side effects, but not much more than the other group. The most common side effects included dyskinesia, nausea, insomnia and dizziness. The study measured participants during their waking hours.
Completion of this trial fulfills the two required trials for a New Drug Application. Impax Pharmaceuticals plans to file for a new drug application with the Food and Drug Administration at the end of 2011.
The Impax Pharmaceuticals clinical trial was a randomized, double-blind, active-control, parallel-group study. It involved participants in both North America and Europe. Impax has also announced that it is teaming up with GlaxoSmithKline to market and sell the drug around the world once it is approved.