One of MJFF’s priorities is to develop a therapy to address the challenges in how levodopa, the gold standard therapy for Parkinson’s disease (PD), is delivered into the body. Many patients who take the drug experience “off” periods, when the effects of the medication wear off before they are ready to take their next dose, leaving them in a state where symptoms like lack of mobility may return. Finding a more consistent method of delivering levodopa could help to minimize these periods, and is therefore one of the critical unmet needs for those living with PD.
Recently, several MJFF awardees have announced progress in work addressing this challenge, and one such company, Impax Pharmaceuticals, is especially close to bringing an improved formulation of the drug to pharmacy shelves. Last month, Impax announced that they had submitted a New Drug Application (NDA) for their drug candidate IPX066 to the U.S. Food and Drug Administration (FDA). IPX066 is an improved extended release capsule formulation of carbidopa-levodopa that has returned encouraging results in clinical trials: Participants in a Phase III clinical trial experienced nearly an hour and a half less “off-time” per day when taking the drug, as compared with carbidopa-levodopa plus entacapone. The NDA review process can typically take up to a year, but according to Suneel Gupta, chief scientific officer at Impax, the company is hopeful that their candidate could be approved before the end of 2012.
Another MJFF awardee, Depomed, announced this month that it had moved into the second phase of clinical study for its own novel gastric-retentive, extended-release formulation of carbidopa/levodopa. While this particular study is being conducted without MJFF investment, an earlier clinical study funded by the Foundation returned results showing improved motor performance in participants with PD.
To date, the practical way that the drug has been absorbed is in pill form. MJFF awardee Civitas Therapeutics, however, is studying an inhaled formulation of levodopa for its potential to produce more rapid and continual relief from the debilitating motor fluctuations that are associated with Parkinson’s. Civitas is in the initial stages of clinical assessment of their drug candidate, called CVT-301. This month, they announced early results showing that a sufficient amount of the compound was found in the blood plasma of patients when inhaled into the lungs. They also reported that the doses administered to trial participants were safe.