Avion Pharmaceuticals, LLC, an Alora Pharmaceuticals company, announced the commercial launch of DHIVY, the first and only carbidopa/levodopa (CD/LD) fractional tablet designed to be divided. Avion gained approval for DHIVY from the FDA in November 2021. This unique design enables more precise medication dosing and directly addresses a market need to assist in titration for the gold standard commonly used by those with Parkinson’s Disease (PD), the fastest-growing neurological condition in the United States, for which there is currently no cure.
DHIVY was developed by two neurologists who recognized the need for a CD/LD tablet that could be easily individualized. The fractional tablet technology is designed with deep scores that enable patients to divide it precisely to match their recommended dose. Each tablet’s four segments contain 6.25/25 mg of CD/LD—the smallest, precise dose available in today’s market. The American Academy of Neurology (AAN) in its updated treatment guidelines for early Parkinson’s disease recommends initiating patients with the lowest effective dose of immediate-release carbidopa/levodopa.
“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 PD management,” said Dr. Leo Verhagen Metman, MD, Rush University Medical Group. “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.”
From 1990 to 2016, the global burden of PD has more than doubled. In the United States alone, there were 1.04 million individuals with PD in 2017, with projected prevalence of 1.64 million individuals by 2037. While CD/LD is the gold standard, and has been the leading treatment for PD, many CD/LD-treated patients report difficulty managing off-time and side effects as a result of difficulties with optimal and precise dosing of the medication. This can lead to complications such as dyskinesia, which can occur when a patient has taken too much CD/LD, or off-episodes that can result in temporary paralysis.
“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 Avion market to help these patients and their providers better manage CD/LD dosing needs with a more individualized experience,” stated Harold “Art” Deas, Chief Executive Officer of Alora Pharmaceuticals. “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.”