The Chinese National Medical Product Administration (NMPA) has approved an investigative new drug (IND) application for Penthrox methoxyflurane inhaler for two different indications, Medical Developments International (MVP or MDI) has announced. MVP is developing Penthrox in China for trauma pain and for procedural pain.
The company said that it plans to complete required clinical bridging studies in China for each of the indications within 12 months. A PK bridging study is also planned. In October 2018, MVP announced that Daiichi Sankyo had acquired the rights to distribute Penthrox in China, Vietnam, and Thailand.
MVP CEO John Sharman commented, “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.”
Sharman continued, “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.”
Read the Medical Developments International press release.
