Avanir Files Complete Response To FDA Approvable Letter For Zenvia

Avanir Pharmaceuticals expects the FDA to classify the response as a Class 2 resubmission, which would result in an expected review period of 180 days and potential approval of Zenvia in the fourth calendar quarter of 2010.

Earlier, in the approvable letter of 2006, the FDA has raised certain safety concerns related to the original Zenvia 30/30mg dose formulation. After discussions with the FDA, Avanir Pharmaceuticals has agreed to reformulate and conduct a confirmatory Phase III trial (Star trial) under a special protocol assessment (SPA) testing new lower dose 30/10 mg and 20/10 mg formulations of Zenvia designed to enhance the safety and tolerability profiles while maintaining clinically meaningful and statistically significant efficacy.

The complete response features data package designed to address the concerns raised in the FDA approvable letter. The filing consists of several modules including the final study reports from the double blind and open-label portions of the Star trial, cardiovascular and respiratory safety white papers, an integrated safety database of subjects exposed to the components of Zenvia at any dose over the past 10 years of development, Avanir Pharmaceuticals’ proposed package insert and a proposed REMS program.

Keith Katkin, president and CEO of Avanir, said: “The filing of our complete response to the FDA approvable letter is another significant milestone for Avanir Pharmaceuticals and represents the culmination of more than three years of hard work and determination by the Avanir Pharmaceuticals team.

“With the help and guidance of the FDA, we were able to improve the benefit-risk profile of Zenvia with new low dose formulations that we believe, if approved by the FDA, can be utilised safely and effectively by patients suffering from the often disabling condition of PBA.”

Randall Kaye, chief medical officer of Avanir, said: “We are thrilled to have filed our complete response with the FDA. Our team worked diligently to compile this comprehensive Zenvia data package which addresses questions and concerns raised by FDA as quickly as possible following the completion of the Star trial at the end of 2009.

“The updated regulatory filing contains approximately twice the number of patient exposures than were included in the original NDA, with over 1,600 subjects exposed and over 500 patient-years of exposure to the components of Zenvia over the past 10 years of clinical development.

“We believe that our response provides the FDA with the data they need to reach a favorable benefit–risk determination associated with Zenvia and that a decision on approval would be possible in the fourth calendar quarter of this year.”