Drug development company Chelsea Therapeutics plans to file a new drug application in the third quarter for its lead drug candidate, an orphan drug for Parkinson’s disease patients.
Charlotte, North Carolina-based Chelsea (NASDAQ:CHTP) reaffirmed the plans following correspondence with the U.S. Food and Drug Administration regarding data from a recent study on its drug candidate Northera. The compound has been developed as a treatment for neurogenic orthostatic hypotension, or NOH, a sudden drop in blood pressure that can result in light-headedness, blurred vision or fainting when a person stands up. The condition is common in people with Parkinson’s disease.
Northera demonstrated efficacy in treating NOH in two late-stage clinical trials whose results were released in 2009. Those results showed anecdotal evidence that Northera also reduced falls experienced by Parkinson’s patients. Fall prevention was studied in another phase 3 trial. But the company in February released trial results showing that although the drug candidate appeared to reduce falls, Northera did not perform better than a placebo for NOH. Chelsea said Monday that it would file its NDA based on the results of the first two phase 3 trials.
The FDA said that fall prevention is an acceptable endpoint for study. But the agency recommended that Chelsea not seek a claim for Northera’s ability to reduce falls in Parkinson’s patients in the initial labeling and instead continue studies of the drug. Depending on those studies, fall reduction could be added to Northera’s labeling after its approval.
The FDA in 2007 granted orphan drug status for droxidopa, the compound that Chelsea plans to market as the drug Northera. Shire Development’s ProAmatine is the only FDA-approved drug addressing orthostatic hypotension. But that drug carries a black-box warning saying the drug may increase the risk of elevating blood pressure when patients are in a reclined position. Orphan drug status is reserved for drugs that treat rare diseases or conditions that have an unmet medical need. The designation gives a drug company a certain period of marketing exclusivity.
