“Are the Inhaler formulations being used in the current CTs the 'dry powder'?”
Current clinical trials
Drug: ZYESAMI™ (aviptadil acetate)
Device: Nebulized administration of ZYESAMI™
TFF Pharmaceuticals has successfully completed formulation work on dry powdered Aviptadil for nasal or pulmonary delivery and is currently undergoing stability testing. Even though TFFP is utilizing the 505(b)(2) regulatory pathway (intended for molecules that have been previously approved by the FDA as safe and effective and can include reformulation of the known molecule in a new strength or dosage form), the dry power compounds still need to undergo full testing. Based on other TFFP compounds, it seems like they need to run stability testing (at least 8 weeks) after which there is an animal study (rat & dog), reactive airway study, toxicology study, IND, Phase 1, Phase 2, etc… Bottom line is that we are likely 2 years away from a portable ‘puff’ inhaler. My opinion.
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