Lexaria Bioscience' Tech Processed Cannabidiol Receives Positive FDA Feedback For Hypertension

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  • Lexaria Bioscience Corp LEXX has received a positive full written response from the FDA from its pre-Investigational New Drug (Pre-IND) meeting regarding DehydraTECH-CBD for hypertension.
  • The FDA confirmed that it agreed with Lexaria's proposal to pursue a 505(b)(2) new drug application regulatory pathway for its program.
  • The pathway is advantageous because this abbreviated pathway, as it is often described, typically enables a faster route to commercial approval than the traditional 505(b)(1) pathway.
  • Also Read: Lexaria Posied To Receive US Patent For DehydraTECH To Deliver Antiviral Drugs.
  • Lexaria's proposed Phase 1b clinical protocol for DehydraTECH-CBD for hypertension in 100 patients received favorably by the FDA to open the IND application to allow Lexaria to work towards full registration of DehydraTECH-CBD for hypertension.
  • The agency also said that additional non-clinical studies are not required before initiating the DehydraTECH-CBD IND program.
  • Lexaria remains on track to file its full IND application with the FDA by late 2022 / early 2023. 
  • Price Action: LEXX shares are down 2.15% at $2.73 during the market session on the last check Wednesday.
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