Mr. Michael Frank of Revive reports
REVIVE THERAPEUTICS ADVANCES MDMA TRANSDERMAL PATCH DEVELOPMENT WITH PURCHASE OF MDMA SUPPLY FROM PHARMALA BIOTECH
Revive Therapeutics Ltd. has initiated the research and development of its novel transdermal microneedle patch to deliver 3,4-methylenedioxymethamphetamine (MDMA). Following the exclusive supply agreement with Pharmala Biotech Holdings Inc. to obtain Pharmala's LaNeo, a GMP (good manufacturing practice) source of MDMA, the company has purchased MDMA supply to support coming IND-enabling (investigational new drug) studies with the MDMA patch.
Recently, Revive Therapeutics announced it entered into a research collaboration agreement with Pharmather Holdings Ltd. to evaluate their microneedle patch technology with MDMA. Pharmather has completed a non-clinical research study with Terasaki Institute for Biomedical Innovation (TIBI) evaluating the delivery of its MDMA patch. Research results from this study will be available in early Q2 2023 and will be used to support future research studies in the United States and potential commercial initiatives in Australia where MDMA can be available to specially licensed psychiatrists to prescribe for certain conditions. In addition, Revive will work with Pharmather, which will finalize a product and clinical development plan to initiate regulatory discussions for future studies in various indications where MDMA may have promise and to finalize certain studies to satisfy the regulatory requirements toward the company's commercial objectives in Australia.
The company believes that the MDMA patch may enable flexible drug load capacity and combinations as well as controlled-release delivery and be able to present desired pharmacokinetic and safety profiles, which could potentially overcome obstacles associated with oral dosing.
"Our clinical and commercial initiatives in broadening our psychedelic product portfolio with our novel MDMA microneedle patch offers a unique delivery method that could expand on the therapeutic utility of MDMA for mental health and abuse disorders," said Michael Frank, chief executive officer of Revive Therapeutics.
About Revive Therapeutics Ltd.
Revive Therapeutics is a specialty pharmaceutical company focused on novel uses and delivery systems for psychedelics, cannabinoids and small-molecule drugs for unmet medical needs, including infectious diseases, rare disorders, and mental health and substance abuse conditions. Currently, the company is exploring using bucillamine as a potential treatment for COVID-19 in a phase 3 clinical study and evaluating rare inflammatory disorders such as ischemia and reperfusion injury from organ transplantation, for which the company received U.S. Food and Drug Administration orphan drug status designation. In addition, Revive is developing a novel psilocybin oral thin film and a transdermal microneedle patch to deliver psilocybin and MDMA.
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