Business
Tetra Bio-Pharma Announces PPP003 Program Update Following Type B Meeting With U.S. FDA
Tetra Bio-Pharma Announces PPP003 Program Update Following Type B Meeting With U.S. FDA.
About this update from Tetra Bio-pharma Inc.
[{"type":"text","content":"\nOTTAWA, June 17, 2019 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc., (“Tetra” or the “Company”) a leader in cannabinoid-derived drug discovery and development (TSX VENTURE:TBP) (OTCQB:TBPMF) today announced that it conducted a Type B meeting with the United States Food and Drug Administration (FDA) for its non-controlled cannabinoid drug product PPP003 slated for the treatment of painful dry eye. The purpose of the meeting was to obtain confirmation of the Phase II clinical study design and the quality and toxicology requirements for initiating this trial in patients in the USA.   \n The FDA confirmed the proposed quality information requirements for initiating the Phase II trial in patients.  This included a container closure system, stability plans, drug substance and drug product specifications.  The FDA also provided feedback on the GLP toxicology requirements to initiate the Phase II trial. The FDA reviewed the proposed Phase II clinical study and agreed that it was acceptable to evaluate the safety and efficacy of PPP003 Ophthalmic Solution for the treatment of the signs and symptoms of painful dry eye. The FDA also provided guidance on acceptable primary and secondary endpoints. \"This program is a corporate priority for Tetra and Panag since there is a significant unmet medical need for ophthalmic drugs,” said Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma. “The choice of the non-controlled cannabinoid was important as the Company is aiming for global market penetration. We are extremely pleased that the U.S. FDA validated our ophthalmic research program.  This program confirms that our research and development team is on the right track.  With this confirmation and guidance, Tetra can now complete the execution of the clinical program for PPP003 intended to target the same important dry eye market as Xiidra™ which was recently acquired by Novartis from Takeda for $3.4Bn with $1.6Bn in potential milestone payments.” About Tetra Bio-Pharma: Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada authorized, and FDA reviewed, clinical trials aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. ...