Lexaria Bioscience Corp. LEXX announced that it has received a positive full written response from the Food and Drug Administration (FDA) from its pre-Investigational New Drug meeting regarding DehydraTECH-CBD for the treatment of hypertension.
The regulatory agency has agreed with the company’s proposal to pursue a 505(b)(2) NDA pathway that enables a faster route to commercial approval.
The company has also proposed a target of 100 patients with hypertension was received favorably by the FDA for the Phase Ib clinical protocol for the treatment of DehydraTECH-CBD.
The agency has acknowledged that non-clinical studies are not required prior to initiation of the DehydraTECH-CBD IND program, based on the compelling data submitted by the company.
John Docherty, President, said, "We are very pleased to have received comments from the FDA toward opening our IND program and we will be executing FDA-confirmed IND-enabling work immediately. We were delighted that our proposals were very well received by the FDA and the feedback received will be very helpful in compiling and filing our IND application as the next major regulatory step we are focused on moving forward.”
Lexaria remains on track to file its full Investigational New Drug (IND) application with the agency by late 2022 or early 2023.
Lexaria shares are trading around 1 percent higher at $2.82 at the time of publication.
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