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Chelsea Therapeutics' CEO Discusses Chelsea Therapeutics Receives Complete Response Letter From Food And Drug Administration For Northera(TM) (droxidopa) Capsules (Transcript)

They further acknowledged that that their guidance is open to the possibility of a single study approval in indications which there is an unmet serious medical need. And that NOH as a condition which is still [awaiting] symptoms with limited treatment options could be a condition for which they will consider an approval based on the results of one study. The letter also states that 301 has many of the characteristics of a single adequate well-controlled study that could make it adequate to support effectiveness.

However the agency's review of the data concluded that there were some subgroups namely women, older patients, US patients and those with Parkinson demonstrated less persuasive results following treatment with Northera and I will note separately that a majority of 301 was conducted in Ex US and that a majority of the US patients participating in the study were through consultation.

They further indicated that these inconsistencies, the results of Study 303 and 303 undercuts the persuasiveness of 301. Finally the letter raised some concerns regarding what they determined to be a disproportionate large favorable effect of one site on the outcome of Study 301. While we would agree that these results impacted the outcome of the 301 our analysis shows that consistent treatment effect is seen across the positive majority of the participating sites and that adjusted for the overall number of participants, results of Study 301 excluding the site would have been persuasive.

The letter also emphasizes the agency's interest in data that adequately demonstrates the durability of the effect. As you'll recall this was also a significant discussion point, both in the agency's briefing document and subsequent advisory committee meeting where the panel ultimately concluded the potential treatment benefits coupled with a significant unmet medical need warranted approval of Northera and outweighed the need for additional study concerning durability prior to the approval ultimately recommending approval of our NDA.

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