NetworkNewsBreaks – Lexaria Bioscience Corp. (NA
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Posted On: 05/11/2023 3:44:19 PM
NetworkNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Announces Completion of cGMP Manufacturing for Upcoming Clinical Trial
Lexaria Bioscience (NASDAQ: LEXX, LEXXW), a global innovator in drug delivery platforms, today announced completion of batch manufacturing of the DehydraTECH(TM)-processed cannabidiol (“CBD”) and placebo materials for its upcoming U.S. phase 1b hypertension clinical trial HYPER-H23-1. According to the update, Lexaria retained the services of a U.S. contract manufacturing organization to produce the materials compliant with current Good Manufacturing Practice (“cGMP”) regulations as mandated by the Food and Drug Administration (“FDA”). Filling into capsules is expected to be completed this month. This will follow with analytical release and stability testing in order to gather essential quality control data necessary for Lexaria’s upcoming Investigational New Drug (“IND”) filing to the FDA, as previously agreed upon in last year’s successful pre-IND meeting as announced on Aug. 10, 2022.
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
Lexaria Bioscience (NASDAQ: LEXX, LEXXW), a global innovator in drug delivery platforms, today announced completion of batch manufacturing of the DehydraTECH(TM)-processed cannabidiol (“CBD”) and placebo materials for its upcoming U.S. phase 1b hypertension clinical trial HYPER-H23-1. According to the update, Lexaria retained the services of a U.S. contract manufacturing organization to produce the materials compliant with current Good Manufacturing Practice (“cGMP”) regulations as mandated by the Food and Drug Administration (“FDA”). Filling into capsules is expected to be completed this month. This will follow with analytical release and stability testing in order to gather essential quality control data necessary for Lexaria’s upcoming Investigational New Drug (“IND”) filing to the FDA, as previously agreed upon in last year’s successful pre-IND meeting as announced on Aug. 10, 2022.
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
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