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Adial Pharmaceuticals Receives European Medicines Agency (EMA) Agreement on the Pediatric Investigation Plan (PIP) for AD04 in Alcohol Use Disorder
EMA Agreement paves the way for a marketing authorization in Europe after Phase 3CHARLOTTESVILLE, VA / ACCESSWIRE / July 22, 2020 / Adial Pharmaceuticals,
About this update from Adial Pharmaceuticals, Inc
[{"type":"text","content":"EMA Agreement paves the way for a marketing authorization in Europe after Phase 3CHARLOTTESVILLE, VA / ACCESSWIRE / July 22, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW) (\"Adial\"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, is pleased to report that the European Medicines Agency (EMA) has accepted its Pediatric Investigation Plan (PIP) for development of the Company's lead drug candidate, AD04, for the treatment of Alcohol Use Disorder (AUD) in the pediatric population, ages 12 to 17. The approved PIP does not require additional clinical trials, and all requirements can be accommodated in the current Phase 3 program.AD04 is under development for the treatment of AUD in persons with certain target genotypes related to the serotonin transporter and receptor genes, and is currently the subject of the landmark ONWARD™ Phase 3 trial that initiated in early 2020. As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. An approved PIP is a prerequisite for filing a Marketing Authorization Application (MAA) for a new medicinal product in the European Union.\"We are delighted by this outcome, which we regard as an important milestone for Adial and young patients suffering from AUD,\" stated Dr. Bankole Johnson, Adial's Chief Medical Officer. \"Early alcohol use is associated with more regular and higher levels of alcohol use and dependence in adulthood, along with increased mental health issues and propensity to incur social harms. With a development plan in place for patients aged 12 to 17, Adial should be well-positioned to address this unmet medical need. The EMA's decision to allow Adial to use historical data to inform pediatric dose through modeling and simulation is notable as this mitigates practically any impact on cost and timeline. Acceptance of Adial's PIP paves the way for the Company's potential submission of an MAA in Europe following completion of AD04's ongoing Phase 3 program.\"About Adial Pharmaceuticals, Inc.Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The Company's lead investigational new d...