FDA approves Kyowa Kirin's new Parkinson's drug Nourianz

The FDA has approved a new drug for Parkinson’s disease, giving the nod to Kyowa Kirin’s Nourianz (istadefylline) as an add-on to dopamine replacement drugs to reduce “off” episodes when the medications are not working well.

Patients taking drugs such as levodopa or carbidopa to top-up dopamine levels, often experience “off” episodes when their symptoms such as tremor and difficulty walking become worse.

There has been little progress in finding new drugs to treat Parkinson’s, a neurological disease caused by the degradation of part of the brain responsible for producing the neurotransmitter dopamine.

In 2017 Newron’s Xadago became the first treatment for patients treated with Parkinson’s to be FDA approved in nearly a decade., although there are other drugs in the pipeline.

Taken as a pill once a day, Nourianz is an adenosine receptor antagonist, which has been studied in four 12-week placebo-controlled clinical studies including a total of 1,143 participants.

In all four studies, patients treated with Nourianz experienced a statistically significant decrease from baseline in daily “off” time compared with patients receiving a placebo.

In the US, around 50,000 people are diagnosed with the disease each year, and around a million Americans have the condition.

The most common adverse reactions observed in patients taking Nourianz were involuntary muscle movement (dyskinesia), dizziness, constipation, nausea, hallucination and sleeplessness (insomnia).

The FDA said that hallucinations, psychotic behaviour, or impulsive or compulsive behaviour occurs, doctors should consider dosage reduction or stoppage of Nourianz.

It’s also recommended that it should not be used during pregnancy and women of childbearing potential should be advised to use contraception during treatment.

Tom Stratford, president of Kyowa Kirin USA Holdings, said: “FDA approval of Nourianz is an important milestone and provides US patients with a novel non-dopaminergic once-a-day oral treatment option to be used in conjunction with levodopa/carbidopa for Parkinson’s disease.”