The Complete Response Letter highlights issues in the Chemistry, Manufacturing, and Controls section of the application.
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to a New Drug Application (NDA) for Rizaport for the treatment of acute migraines, announced IntelGenx Corp.
Rizaport is an oral film formulation of rizatriptan benzoate, the active drug in Maxalt. The soluble oral formulation could provide an alternative for patients with migraine who experience dysphagia or migraine-related nausea.
The CRL highlighted issues in the Chemistry, Manufacturing, and Controls section of the application. The FDA asked for more information from the company but did not request a new bioequivalence study.
"We believe the recommendations stated in the CRL are manageable and we remain committed to working closely with the FDA to make this innovative new oral film product available to people suffering from migraines,” said Horst G. Zerbe, PhD, President and CEO of IntelGenx.
This is not the first CRL that IntelGenx and partner company, RedHill Biopharma have received for the oral film rizatriptan benzoate. Following a March 2013 NDA submission, the companies received a CRL from the FDA. That CRL also addressed issues with the Chemistry, Manufacturing, and Controls section of the Rizaport application. The CRL led to a resubmission to the FDA in November 2017 that the FDA accepted in November 2018, setting a PDUFA date of April 1, 2019.
Zerbe said the company would again resubmit a New Drug Application for rizatriptan benzoate oral film by the end of quarter 3 2019. “To that end, we expect to move quickly,” he added.