Dhivy, Carbidopa/Levodopa in Divisible Tablet for Dosing, Enters US
According to Avion, Dhivy is the first and only such therapy available as a tablet with four snappable segments, allowing for more precise dosing of carbidopa/levodopa.
“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,” Harold Deas, CEO of Alora Pharmaceuticals, said in a press release. Avion, a specialty pharmacy, is an Alora subsidiary.
“While no two patients with Parkinson’s Disease are the same, the burden all patients face is significant. Avion is pleased to bring Dhivy to the market to help these patients and their providers better manage CD/LD [carbidopa/levodopa] dosing needs with a more individualized experience,” Deas added.
Levodopa and its derivatives are mainstay treatments for Parkinson’s. The disease is caused by the death and dysfunction of neurons (nerve cells) in the brain that make dopamine, an important neurotransmitter — a chemical these cells need to communicate with each other and the rest of the body. Levodopa is basically a raw ingredient that nerve cells use to make dopamine.
Once ingested, levodopa can travel to the brain and be converted to dopamine; the increase in dopamine signaling helps to ease Parkinson’s symptoms. Carbidopa is typically given alongside levodopa to help prevent it from being broken down in the body, allowing more of the active therapy to enter the brain and be converted.
Treatment with carbidopa/levodopa can be challenging, as optimal use of these therapies requires precise timing and dosages. Too low a dose can fail to control symptoms, while those that are too high can increase the risk of dyskinesia (uncontrolled movements) and other side effects.
Dhivy tablets come in four breakable sections, with each section containing 6.25 mg of carbidopa and 25 mg of levodopa. As such, patients can take an entire tablet (25 mg carbidopa/100 mg levodopa) or one or more sections, making Dhivy “the smallest, precise dose available in today’s market,” Avion reports.
“Fine tuning each individual’s optimal CD/LD dose in increments of less than 50 mg of levodopa is extremely unreliable. The option to accurately and reliably fractionate the CD/LD dose in 6.25/25 mg increments provides physicians and patients with the long-overdue possibility to better personalize [Parkinson’s] management,” said Leo Verhagen Metman, MD, a neurologist with Rush University Medical Center in Chicago.
“This can be helpful not only for brittle patients who aim to navigate the rocky road of motor fluctuations and dyskinesia, but also for those with milder disease who want to take no more CD/LD than strictly needed,” Metman added.
Dhivy was approved by the U.S. Food and Drug Administration in November 2021.