Medical Developments International (MVP) said that the company in no longer planning to conduct clinical trials of its Penthrox methoxyflurane inhaler in China due to “extended delays to the anticipated timeline for clinical trial outcomes and consequently the commercial launch of Penthrox in the market, primarily due to the challenging regulatory environment and COVID restrictions.”
In November 2019, the company announced that Chinese regulators had approved an IND for Penthrox and that trials were planned to evaluate the inhaler for both trauma pain and procedural pain. Daiichi Sankyo had acquired the rights to distribute Penthrox in China in 2018.
In the US, the FDA issued a clinical hold letter in 2018 that delayed clinical trials of Penthrox; MVP announced in March 2022 that the agency had lifted that clinical hold. Penthrox has been marketed in the EU for the emergency treatment of moderate to severe pain in trauma patients since 2017. In 2019, MVP bought back the EU rights to Penthrox from Mundipharma.
MVP CEO Brent MacGregor said, “A commercial launch in China is not a strategic priority at this time. We are directing our resources into those projects that have greater capacity to generate shareholder value in the nearer term. These projects include accelerating penetration of Penthrox in select European markets and in Australia. In the longer-term, we intend to deliver the next wave of growth through Penthrox entry into the US. Following the FDA’s lifting of the clinical hold, this process has already commenced.”
Read the Medical Developments International announcement.
