San Diego-based PassPort Technologies, Inc. (PPTI) has launched a Phase 1 clinical trial in the United States for the Zolmitriptan PassPort® system, which employs a unique transdermal microporation system. The trial aims to assess the safety and pharmacokinetics of the system, with an expectation of a quicker therapeutic effect than the traditional oral form of zolmitriptan. Zolmitriptan, known under the brand ZOMIG®, is a medication authorized by the FDA for migraine treatment. Tomoyuki Fujisawa, PPTI's President and CEO, expressed confidence in the system's potential to offer rapid relief and enhanced efficacy, particularly for patients experiencing severe nausea or those unresponsive to oral triptans.
The clinical trial is an open-label, randomized, crossover design involving 32 healthy individuals to test Zolmitriptan PassPort® at three varying doses applied to the upper arm. It will also examine the transdermal application at alternative body sites, such as the abdomen and thigh, with preliminary pharmacokinetic results expected to be disclosed in March 2024.
PPTI, a pioneering biotech company, is dedicated to the rapid advancement and distribution of superior pharmaceuticals via the PassPort® system. The company's goal is to innovate technologies that benefit the pharmaceutical and life sciences industries, with a vision to improve global health outcomes.
The PassPort® System is a blend of patented painless skin microporation and dry patch formulation technologies, facilitating the controlled delivery of drugs through skin micropores. This system is capable of transdermally delivering a range of therapeutic agents, including small molecules, peptides, proteins, and RNAs, as well as vaccines for infections.
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