The Medical Developments International (ASX: MVP) share price is up 8% after making an announcement to investors.
Medical Developments International is a healthcare company focused on emergency pain relief and respiratory products. The company manufactures Penthrox, a fast onset, non-opioid analgesic indicated for pain relief by self-administration in patients with trauma and those requiring analgesia for surgical procedures. It has been used in Australia for over 40 years. It’s used in hospitals including emergency departments, Australian Ambulance Services, the Australian Defence Forces, Sports Medicine and for analgesia during short surgical procedures such as dental and cosmetic surgery. It’s growing internationally and also manufactures a range of asthma respiratory devices.
Medical Developments’ Latest Expansion
The healthcare company announced that the Chinese National Medical Product Administration (NMPA) has approved the opening of Medical Developments’ Investigative New Drug (IND) application.
Medical Developments said that this application is a critical step and building block to having Penthrox approved for sale in China.
The company’s submission in China is to have Penthrox approved for two separate indications. The first is for trauma pain and the second is for procedural pain.
Management said that the company has commenced work to complete clinical bridging studies required in China for each indication and expect them to be completed within the next year. It’s also doing a bridging Pharmacokinetic (PK) study. The purpose of this study is to support the use of Penthrox with Chinese people and will be used as an additional piece of evidence to the global clinical data the company has already given to the NMPA and other global authorities.
Medical Developments CEO 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.”
[ls_content_block id=”18457″ para=”paragraphs”]
[ls_content_block id=”18380″ para=”paragraphs”]
