PassPort Technologies, Inc., a San Diego-based firm specializing in the development of pharmaceuticals and medical devices, has reported favorable preliminary outcomes from a Phase 1 clinical trial of their Zolmitriptan PassPort® system. This system employs a proprietary transdermal microporation technology to administer zolmitriptan, an FDA-approved drug for migraine treatment, in a needle-free manner.
The Zolmitriptan PassPort® system, which includes a microporation device and a patch, was applied to the upper arm of participants, allowing for painless and efficient delivery of the medication into the bloodstream through micropores created in the skin. The trial involved 32 healthy individuals and assessed the tolerability and pharmacokinetics of the system at three dosage levels (0.75 mg, 1.5 mg, and 3.0 mg) in comparison to a 2.5 mg oral dose of zolmitriptan.
The system proved to be well-tolerated, with no serious adverse events reported. Notably, zolmitriptan was detectable in the plasma just two minutes post-administration with the PassPort® system, which is significantly quicker than the 15-minute timeframe observed for oral intake. Additionally, the bioavailability of the system was found to be between 160% and 200% higher than that of the oral form.
Tomoyuki Fujisawa, President and CEO of PassPort Technologies, expressed optimism about the system's potential benefits for migraine sufferers, particularly those with severe nausea or those who do not respond well to oral triptans. He anticipates that Zolmitriptan PassPort® will emerge as a leading product option in its class.
The ongoing Part B of the study is set to evaluate the transdermal administration of a single dose at alternative body sites, such as the abdomen and upper thigh, with final results expected to be disclosed in the third quarter of 2024. PassPort Technologies holds the exclusive rights to develop and market the Zolmitriptan PassPort® system and is considering partnering for further clinical development and commercialization.
The company is dedicated to the rapid advancement and patient access to innovative pharmaceuticals through its PassPort® system, which integrates patented painless skin microporation with dry patch formulation technologies. This system is capable of delivering a range of therapeutics, including small molecules, peptides, proteins, and RNAs, for various treatments and vaccines.
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