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news.The FDA has accepted Chelsea Therapeutics' investigational new drug application for Droxidopa, an orally active synthetic precursor of norepinephrine currently approved and marketed in Japan for the treatment of orthostatic hypotension.
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This acceptance of this investigational new drug (IND) application will permit Chelsea to commence its pivotal Phase III clinical trials in neurogenic orthostatic hypotension (NOH). Chelsea plans to conduct two pivotal trials in NOH (Studies 301 and 302) evaluating a combined total of up to 236 patients.
Both pivotal efficacy trials will utilize an enrichment design where all potential participants are initially screened to demonstrate both a blood pressure and symptomatic improvement with Droxidopa prior to randomization to either placebo or active treatment.
Dr Simon Pedder, Chelsea’s president and CEO, said: “This IND enables Chelsea to move directly into the final stages of clinical development required for the US approval of Droxidopa as a safe and effective treatment for NOH. We are pleased to have met all the regulatory requirements necessary to initiate our pivotal trials in NOH and look forward to initiating enrollment later this year.”