Acute Migraine Treatment Gets FDA Complete Response Letter

The 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.

This article was originally published by MD Magazine.

Stay up to date on the latest news in specialty pharmacy by getting Specialty Pharmacy Times in your mailbox or inbox for free!

Click here to sign up for free for the bi-monthly Specialty Pharmacy Times print journal delivered to your address.

Click here to sign up for our email newsletters delivered every Monday, Wednesday, and Friday, in addition to breaking news alerts.

Click here to follow us on Facebook. 

Click here to follow us on Twitter. 

Click here to join our LinkedIn group. 

Related Articles

The study evaluated the activity and tolerability of venetoclax combined with cytarabine or cytarabine/idarubicin in pediatric patients with relapsed/refractory acute myeloid leukemia.
Gilteritinib (Xospata, Astellas Pharma) is indicated for adults with relapsed/refractory acute myeloid leukemia with an FMS-like tyrosine kinase 3 mutation.
Study suggests a possible co-treatment strategy to overcome resistance to Venetoclax in the treatment of chronic lymphocyte leukemia and acute myeloid leukemia.
Company Profile >
Industry Guide >
Market News >
Peer Exchange >
Conferences >
Subscribe >
Specialty Times Resources
About Us
Contact Us
Terms & Conditions
MJH Associates >
Pharmacy Times
American Journal of Managed Care
MD Magazine
Targeted Oncology
Physicians' Education Resource
Pharmacy & Healthcare Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright Specialty Pharmacy Times 2006-2019
Pharmacy & Healthcare Communications, LLC. All Rights Reserved.