PERTH: Medical Developments International Limited (MVP) announced the Chinese National Medical Product Administration (NMPA) has approved the opening of MVP’s Investigative New Drug (IND) application.
This application is a critical step and building block to having Penthrox approved for sale in China. MVP’s submission in China is to have Penthrox approved for two separate indications. The first is for Trauma Pain and the second for Procedural Pain.
MVP has commenced work to complete clinical bridging studies required in China for each indication and expect them to be completed within 12 months. In addition, MVP is undertaking a bridging Pharmacokinetic (PK) study. The studies are designed to support the use of Penthrox in Chinese people and will be used as an adjunct to the global clinical data MVP already has submitted to the NMPA and other global authorities.
Chief Executive Officer of MVP, Mr. John Sharman, said: “The approval of the Penthrox IND by the Chinese authorities is a significant milestone for our company. The NMPA has accepted the safety and efficacy of the global clinical data. The clinical program we are undertaking in China comprises small studies designed to support the safety and efficacy of Penthrox in Chinese people.”
Mr. John Sharman said: “Our partner in China, Daiichi Sankyo, is Japan’s biggest pharmaceutical company, which is expanding aggressively in China. The Chinese market has an unmet need for a strong non opioid analgesic like Penthrox and the ultimate approval by the NMPA of Penthrox will be very positive for MVP and Daiichi Sankyo.”Chairman of MVP David Williams said that “the Chinese IND is a ‘red letter’ day of us and a very exciting milestone.”