AbbVie Inc has received a complete response letter (CRL) from the US Food and Drug Administration requesting additional information on a pump that is used to deliver its candidate treatment for Parkinson’s disease, the company announced on 22 March. A CRL is a formal notice from the FDA to a company outlining deficiencies in a new drug application (NDA). The agency did not request additional safety or efficacy studies. AbbVie said it plans to resubmit its regulatory application as soon as possible.
The candidate drug, ABBV-951 (foscarbidopa/foslevodopa), is a soluble formulation of the levodopa and carbidopa prodrugs that is delivered as a continuous infusion. The company’s regulatory application was based on the results of a Phase 3 trial which showed that patients receiving the treatment had improved motor fluctuations after treatment, with benefits in both ‘on time’ when Parkinson’s symptoms are under control, and ‘off time’ when symptoms are no longer controlled. In the trial, the drug was compared with an oral immediate-release carbidopa/levodopa combination.