Northera, the troubled Chelsea Therapeutics (NASDAQ:CHTP) drug candidate to treat dizziness and fainting in some Parkinson’s disease patients, now gets a second chance.
Charlotte-based Chelsea said today that the company has enough clinical data to resubmit a Northera drug application nearly a year after the the Food and Drug Administration declined to approve the drug. Chelsea said it plans to file a new drug application late in the second quarter.
“We now have a regulatory path forward, including the potential for an approval of Northera later this year,” Joseph Oliveto, interim CEO of Chelsea said in a statement.
Northera was developed to treat neurogenic orthostatic hypotension, or NOH, a condition in which patients experience dizziness and fainting upon standing due to low blood pressure. Though rare, NOH can be found in patients with Parkinson’s disease, multiple systems atrophy and pure autonomic failure. Patients who have NOH have few treatment options because Shire’s midodrine– the only FDA-approved NOH drug – carries a black box warning due to health risks.
Chelsea’s failure to win Northera approval last year sent the company’s stock into a tailspin. The company implemented cost-cutting measures and layoffs. Former CEO Simon Pedder resigned in July. The company planned to focus its efforts on an already planned phase III trial studying Northera’s effect on preventing falls in Parkinson’s patients who have NOH. The company changed the focus of that study to evaluate Northera’s effect on NOH symptoms.
Results for that late-stage Northera study showed statistically significant improvement in addressing dizziness and lightheadedness. Incidentally, reducing falls and falls-related injuries — the original focus of this study – showed results that were not statistically significant.
Chelsea said that the the FDA’s guidance suggests that trial results showing short-term clinical benefit from Northera study would be adequate for approval. But if the drug secures FDA approval, Chelsea might face a requirement to continue studying whether the drug’s benefits last beyond the short term.
