Dhivy™, a carbidopa/levodopa tablet formulation designed to facilitate dose adjustment, is now available for the treatment of Parkinson disease, postencephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
Dhivy is supplied as a functionally scored tablet containing 25mg of carbidopa and 100mg of levodopa. Each tablet has 3 scores with each segment containing 6.25mg of carbidopa and 25mg of levodopa. The tablets can be broken at the score lines if a patient has difficulty swallowing it due to size.
The Food and Drug Administration (FDA) approved Dhivy in November 2021 based upon bioavailability studies comparing Dhivy to an immediate-release tablet containing 25mg of carbidopa and 100mg of levodopa. Following single oral administration of a Dhivy tablet, Dhivy was found to be bioequivalent to the immediate-release product under fasting conditions for both carbidopa and levodopa.
Commenting on the product launch, Harold “Art” Deas, Chief Executive Officer of Alora Pharmaceuticals, said: “The innovative tablet design provides a new way to individualize every dose and mitigate some of the challenges patients currently face when it comes to their medication management.”
In November 2021, the American Academy of Neurology released updated guidelines on initiating dopaminergic therapy for motor symptoms in early Parkinson disease. According to the guidelines, initial treatment with levodopa was found to provide greater benefit for motor symptoms compared with either dopamine agonists or MAO-B inhibitors. To optimize benefit and reduce the risk of dyskinesia, it was noted that the lowest effective dose should be prescribed.
Avion Pharmaceuticals, LLC, an Alora Pharmaceuticals company, announces the FDA approval and availability of Dhivy™ for the treatment of Parkinson’s disease. News release. Avion Pharmaceuticals, LLC. Accessed February 14, 2022. https://www.prnewswire.com/news-releases/avion-pharmaceuticals-llc-an-alora-pharmaceuticals-company-announces-the-fda-approval-and-availability-of-dhivytm-for-the-treatment-of-parkinsons-disease-301481295.html