The FDA has issued a complete response letter to Orexo’s NDA for OX124 intranasal dry powder naloxone for the reversal of opioid overdose, the company said. Orexo resubmitted the NDA in September 2023 after the agency rejected its first application due to concerns about the packaging process. The NDA had been initially submitted in early 2023. The FDA accepted the resubmitted application for OX124 in November 2023 and set a PDUFA goal date of July 15, 2024.
According to Orexo, the CRL includes a request for an additional human factors study, which was expected based on previous FDA comments and which has already been concluded. In addition, the CRL included a request for “technical data” from commercial scale product, which the company said it had not anticipated, adding that “Orexo will now work expeditiously in consultation with the FDA to address this to enable a resubmission of the NDA to FDA as soon as possible.”
Orexo President and CEO Nikolaj Sørensen commented, “I am impressed by the vigor and agility of the teams in Sweden and the US in addressing FDA’s concerns from April regarding the instructions for use and our ability to complete a new human factors study shortly. However, I am surprised with the agency’s other requests with regards to additional technical data from final commercial product, but I am confident we can address this efficiently. We remain confident our powerful life-saving medication, OX124, can contribute to reducing the steep number of Americans who die from overdoses caused by the increasingly prevalent synthetic opioids. Me and my team are determined to continue taking the necessary actions to swiftly provide the FDA with the additional information.”
Read the Orexo press release.
