Chelsea therapeutics celebrates positive Phase III Northera results
This article was originally published in Scrip
Chelsea Therapeutics' Northera (droxidopa) met its primary endpoint in a second pivotal trial for neurogenic orthostatic hypotension (NOH), providing relief for the company after an earlier Phase III failed. The progress is particularly welcome in light of the faltering of Shire's ProAmatine (midodrine): ProAmatine is approved in the US for NOH, but the FDA is currently considering rescinding approval due to a lack of efficacy data. The top-line data sent Chelsea shares up around 40% between 17 and 20 September, to settle at $5.73 on Nasdaq.
NOH is a chronic condition in which patients experience a debilitating drop in blood pressure upon standing. It is particularly prevalent in patients with Parkinson's disease. In Chelsea’s latest trial, 160 patients were treated with either placebo or Northera for one week. Those on Northera experienced on average a 1.83 point improvement in the OHQ, compared with a 0.93 improvement in the placebo group (p=0.003). Treatment also increased mean standing systolic blood pressure, and was associated with fewer falls, compared with placebo. The most common adverse event was headache.
"We are extremely excited by these top-line results which provide validation of the safety and efficacy of Northera," said Simon Pedder, Chelsea’s president and CEO.
The company attributed the failure of its earlier pivotal trial to a strong placebo effect. In the second trial, it switched from a measure of dizziness to a relative mean change in results of the 11-point orthostatic hypotension questionnaire (OHQ) and enrolled more patients.
An additional pivotal Phase III trial of Northera, in patients with Parkinson's disease, continues and is due to report next year.
The β adrenoreceptor agonist was first launched, in Japan, in 1989, where it is approved for NOH.
It is also in Phase II development for fibromyalgia, adult attention deficit disorder and intradialytic hypotension (IDH).