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FDA wants new study from Inspire
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DURHAM, N.C. — Federal regulators are asking Inspire Pharmaceuticals to perform a new study of its dry eye treatment in order to confirm the drug’s efficacy, according to a statement from the company. Shares of Inspire’s stock dropped 8% in value when this news was made public last week.
In a press release, Inspire officials said they initially believed a phase 3 study of the company’s diquafosol tetrasodium ophthalmic solution for the treatment of dry eye would be enough to satisfy U.S. regulators, who had asked for additional data before granting approval. In a press release issued last week, the company announced that the Food and Drug Administration decided the findings from Inspire’s existing study are not sufficient to address the requirement for an additional clinical study that were outlined in an “approvable” letter the company received last year.
According to Christy Shaffer, PhD, chief executive officer of Inspire, the company is already planning the additional study to meet the FDA’s requirements. She said the company plans to involve the FDA in a review of the study protocol to ensure that the study design is acceptable.