2015年01月09日
(2015-01-09 22:44:20)The US Food and Drug Administration (FDA) has approved an extended-release capsule formulation of carbidopa-levodopa (Rytary, IPX066, Impax Pharmaceuticals) for the treatment of Parkinson's disease (PD), postencephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
The product contains immediate-release and extended-release beads, with a specific amount of carbidopa and levodopa in a 1:4 ratio, and provides both initial and extended levodopa plasma concentrations after a single dose, the company said in a statement. The capsule may be swallowed whole or, for patients who have trouble swallowing, the capsule may be opened and the beads sprinkled on applesauce and consumed immediately.
Impax expects this formulation to be available beginning next month in four strengths: 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg, and 61.25 mg/245 mg (carbidopa/levodopa).
The company received a
The approval was based on positive results in a trio of phase 3 studies involving patients with early and advanced PD in the United States and in Europe.
In the
Treatment was also associated with mean improvements of 72% in both
Clinician Global Impression of change (CGI) and Patient Global
Impression of change (PGI) compared with 27% and 34% for placebo in
CGI and PGI, respectively (P
In the
In the
The most common adverse reactions in clinical trials were nausea, dizziness, headache, insomnia, abnormal dreams, dry mouth, dyskinesia, anxiety, constipation, vomiting, and orthostatic hypotension. This product is not for use in patients taking nonselective monoamine oxidase inhibitors. Hypertension can occur if these drugs are used concurrently.
Rytary is designed to address "one of the most significant unmet needs for patients living with Parkinson's disease, which is to reduce the amount of time during the day when their symptoms are not adequately controlled," Fred Wilkinson, president and CEO, Impax Laboratories, said in the company news release.