AbbVie announced that the US Food and Drug Administration (FDA) had delivered a Complete Response Letter (CRL) in response to the company’s new drug application (NDA) for ABBV-951 (foscarbidopa/foslevodopa).
ABBV-951 is a potential treatment for motor fluctuations in adults with advanced Parkinson’s disease. AbbVie outlined that the CRL was due to the FDA requesting additional information about the device, as part of the NDA review. The company added that the CRL did not request any additional efficacy and safety trials related to the drug.
The device that delivers the treatment is a pump that has been designed to dose the therapy over a 24-hour period, providing continuous subcutaneous delivery of foscarbidopa and foslevodopa.
“There is an unmet need for people living with advanced Parkinson's disease as they face daily challenges in managing their condition. We will continue to work closely with the FDA as part of our commitment to bringing this treatment option to people impacted by this disease as quickly as possible,” said Thomas Hudson, chief scientific officer at AbbVie.
AbbVie already markets carbidopa and levodopa as a combination treatment under the Duopa brand. However, in a study comparing ABBV-951 against oral immediate-release carbidopa and levodopa, the drug candidate was shown to be statistically superior at controlling motor fluctuations.
Another advantage of subcutaneous delivery was found to be the ability to improve ‘On’ time, without dyskinesia, compared to the oral treatment. The terms ‘on’ and ‘off’ refers to episodes between doses where symptoms recur.
The longer the patient receives levodopa, the more likely it is that the treatment will stop being as effective. This can be compensated for by increasing the dosage of the drug or increasing the dosing frequency, however, this can lead to dyskinesia. This condition is used to describe patients that experience unintended, involuntary and uncontrollable movements.
ABBV-951 is delivered via a pump, typically placed in the abdomen, and therefore the drug combination can be absorbed directly into the bloodstream. As a result, more consistent amounts of levodopa can be delivered to the brain, which is able work quicker and reduce off times.
In phase 3 trials, off times for participants were reduced by an average of about three hours, and also experienced a relative increase in daily on times.
The company stated that it plans to resubmit its NDA “as soon as possible.”