Late Stage Trial Shows Parkinson’s Drug Efficacy

(Photos8.com)

Biotechnology company Impax Laboratories Inc. in Hayward, California  says that a Phase 3 clinical trial of its drug IPX066 shows it is effective in patients with early Parkinson’s disease (PD), with side effects similar to related PD drugs in use. A Phase 3 trial studies a drug or treatment given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

Impax says IPX066 is an investigational extended release levodopa-carbidopa treatment intended to produce a fast and sustained concentration of levodopa, for improving PD clinical symptom management. Levodopa, when it enters the brain is converted to dopamine. Carbidopa is added to the levodopa to prevent the breakdown of levodopa before it crosses into the brain.

The trial met its primary efficacy objective on the Unified Parkinson’s Disease Rating Scale measures of daily living activities and motor symptoms of PD. All three doses of IPX066 showed significant improvement compared to placebo. The results, says Impax, indicate an improvement in PD symptom severity reductions in early PD patients as a result of IPX066 treatment. Other standard measures, including clinicians’ impressions of change, patients’ impressions of change, and quality of life also scored higher in the patients receiving the treatment versus the placebo.

The company says the most commonly reported adverse events in the IPX066 treatment groups included nausea, headache, and dizziness which are common in carbidopa-levodopa products. The proportion of subjects experiencing adverse events was similar for IPX066 and placebo treated subjects (69% compared to 73%, respectively). No unexpected drug-related serious adverse events were observed in IPX066 treated subjects.

The trial was a randomized, double-blind, placebo controlled, parallel group, fixed-dose study comparing 3 doses of IPX066 to placebo in patients with early Parkinson’s disease. The trial enrolled 381 subjects in North America and Europe who were randomized to receive one of three doses of IPX066 or matching placebo administered orally three times per day for 30 weeks.

Related: Biotech Company to Partner with Scripps on Parkinson’s Drugs

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