MVP updates on FDA delays

Company News

Medical Developments International (ASX:MVP) has updated investors on recent discussions with the US FDA regarding its submission for Penthrox.

Penthrox is a fast onset, non-opioid analgesic for pain relief by self-administration in patients with trauma and those requiring analgesia for surgical procedures.

According to the company, the FDA has delayed its responses to nearly all submissions as a result of the workload in its Division of Anesthesia, Analgesia, and Addiction Products.

"The FDA estimates a delay in its response until the end of June," said the company.

"The FDA confirmed the delay is not related to Penthrox. The FDA indicated that MVP was 'well placed', as many other FDA responses are being delayed to September," it added.

MVP CEO, Mr John Sharman said: “The feedback from the FDA is not unexpected given the epidemic of narcotic addiction in the USA and the political pressure this is generating. We are encouraged by the informal feedback that the review of our non-narcotic Penthrox is towards the top of the list. We will keep the market informed.”