Business
MED3000 commercial and US regulatory update
MED3000 commercial and US regulatory update.
About this update from Futura Medical Plc
[{"type":"text","content":"\n \n \n \n \n \n 14 March 2023\n \n \n \n \n \n \n Futura Medical plc\n \n \n \n \n (\"Futura\" or the \"Company\")\n \n \n \n \n \n \n \n \n \n Futura confirms initial launch of MED3000 under the Eroxon® brand\nand continued progress towards regulatory approval in US\n \n \n \n \n \n \n \n \n Futura Medical plc (AIM: FUM), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology and currently focused on sexual health and pain, today provides updates on commercial and US regulatory activities for MED3000,\n Futura's\n novel, topical gel formulation for the treatment of erectile dysfunction (\"ED\")\n .\n \n \n \n \n \n \n Eroxon launch\n \n \n \n In May 2022, Futura announced an exclusive licensing agreement with\n Cooper Consumer Health\n , a leading International independent self-care organisation\n for the rights to commercialise MED3000 throughout the EEA, the United Kingdom and Switzerland.\n \n \n \n \n \n Futura is pleased to report that MED3000, under the brand name Eroxon™ is now available online in Europe. On the 1st of April 2023 Eroxon will also be available in retail pharmacies in Belgium supported by an advertising and promotional campaign. Futura also confirms that further country launches, supported by advertising and promotional campaigns, remain on track during the coming months, as previously guided.\n \n \n \n \n \n \n FDA Update\n \n \n \n I\n n October 2022 Futura filed an application for US marketing authorisation for the MED3000 medical device via the De Novo regulatory pathway which is undergoing detailed review. As a regular part of its review process, FDA have asked some additional questions and requested some non-clinical confirmatory data. The company expects to provide a full response to FDA's questions as well as the requested confirmatory data no later than the end of March 2023, to enable FDA to complete their review.\n \n \n \n \n \n Based on FDA's published target review period guidelines to include time to review the newly provided information, grant of the De Novo request is now expected to be achieved in Q2 2023.\n \n \n \n \n \n MED3000 is the Company's breakthrough, topical gel formulation for treatment of erectile dysfunction (\"ED\"). It has ...