Penthrox IND approved in China

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Medical Developments International (ASX:MVP) has announced that the Chinese National Medical Product Administration (NMPA) has approved the opening of its Investigative New Drug (IND) application for Penthrox.

MVP said its submission in China is to have Penthrox approved for two separate indications. The first is for Trauma Pain and the second for Procedural Pain.

It said it 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," said the company.

According to CEO John Sharman, “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.”

“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,” he added.