Announced that it has successfully completed an End-of-Phase 2 ending up in the FDA for ARX-01 today, a drug/device combination product based on the business’s proprietary NanoTab dosage type, which enables delivery of sufentanil by the non-invasive oral transmucosal path. ARX-01 offers a non-invasive option to intravenous patient-controlled analgesia for the management of acute post-operative pain in the hospital setting. The FDA examined a package based on positive Phase 2 clinical study results from three Phase 2 trials which demonstrated the efficiency of the ARX-01 device and the basic safety and efficacy of Sufentanil NanoTabs for the treating moderate-to-severe acute agony following knee replacement surgery and abdominal surgery.
The Stage I/II clinical research is scheduled to begin before 2013. This partnership leverage’s AMT’s proven knowledge in cGMP developing of gene therapy items and our encounter in progressing the products through clinical advancement and the regulatory processes needed for effective commercialization, stated Jorn Aldag, CEO of AMT. Furthermore, we will have a choice to acquire full commercial rights for the program on completion of the Stage I/II study, which supports our strategy to create a pipeline of orphan and ultra-orphan indications. Related StoriesStudy suggests potential brand-new way to block cancer-causing geneSingle gene variation may influence obesity in children, adultsMU researchers successfully treat canines with DMD, plan for human clinical trialsMuriel Eliaszewicz, Medical Director of Institut Pasteur, stated: AMT is one of the only companies in the world which has a proven ability in making cGMP quality gene therapy products, not only in batches sufficient for clinical advancement but also in support of a potential regulatory acceptance. Continue reading “A drug/device combination product based on the businesss proprietary NanoTab dosage type.”