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Incannex Appoints QPS to Advance CannQuit-N™ (Nicotine), CannQuit-O™ (Opioid) and Renecann™ Products in the USA and EU
MELBOURNE, Australia, April 14, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Ltd (Nasdaq: IXHL) (ASX: IHL) (‘Incannex’ or ‘the Company’) a pharmaceutical
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"MELBOURNE, Australia, April 14, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Ltd (Nasdaq: IXHL) (ASX: IHL) (‘Incannex’ or ‘the Company’) a pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic assisted psychotherapies for unmet medical needs, is pleased to announce that is has appointed Quest Pharmaceutical Services (‘QPS’) to provide regulatory advice and manage clinical trials for the development of CannQuit™ and ReneCann™ products for addiction and immune-disordered skin diseases. QPS was founded in 1995 to provide high-quality bioanalytical LC-MS/MS contract services. Since then, QPS has grown from a small molecule bioanalysis shop of three people to more than 1,250+ employees in the United States, Europe, India, and Asia. Over the years, QPS has adopted additional services, including Neuropharmacology, DMPK, Toxicology, Translational Medicine, Early Phase Clinical Research and Phase II – IV Clinical Research. QPS is currently drafting pre-investigational new drug (pre-IND) submissions for both the European Union’s European Medicines Agency (‘EMA’) and the US Food and Drug Administration (‘FDA’) for the CannQuit™ and ReneCann™ Products. Once advice is received from the regulators over the proposed research and development programs, QPS will retain a leading role in the management of clinical trials, which will be undertaken to provide relevant evidence of safety and efficacy. CEO and Managing Director, Mr Joel Latham said; “QPS is a perfect fit for us to develop these products across the globe. Not only will QPS assist us with conducting clinical research, it has been engaged to advise upon the quickest route to commercialising the products in different regulatory jurisdictions.” The CannQuit™ and ReneCann™ products are patent protected and were acquired as part of the acquisition of APIRx Pharmaceuticals (‘APIRx’), completed in 2022. These products are being developed and manufactured by Eurofin’s Scientific (Eurofins). Data collected by Eurofins on the quality and stability of the products will be key components of future regulatory packages. CannQuit-Nicotine (N)™ A functional, controlled-release, pharmaceutical-grade (cGMP) medicated chewing gum formulation comprising cannabidiol (CBD) and nicotine. Drug product development and testing is underway at Eurofins. Nicotine chewing gum i...