Regulatory Decision Summary for Vilazodone hydrochloride (VIIBRYD)

 

Decision issued

A Notice of Deficiency was issued by Health Canada. The company cancelled its submission before a final decision was issued.

Date of cancellation

October 24, 2018

What was the purpose of this submission?

The purpose of this Supplemental New Drug Submission (SNDS) was to support a new indication for the treatment of General Anxiety Disorder (GAD).

What did the company submit to support its submission?

To support a new indication for GAD, the sponsor submitted pre-clinical and clinical components. The clinical portion included clinical pharmacology studies and 3 pivotal phase III clinical safety and efficacy studies. The pivotal studies were:

VLZ-MD-05 - an 8-week double-blind, placebo-controlled, parallel group, fixed-dose study of vilazodone 20 mg and vilazodone 40 mg vs placebo in 667 randomised patients.

VLZ-MD-06 and VLZ-MD-07 - 8-week, double-blind, placebo-controlled, parallel group, flexible-dose studies of vilazodone 20 to 40 mg vs placebo in 395 and 400 randomised patients, respectively.

What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?

At the time of the cancellation, Health Canada had completed the review of one pivotal trial (VLZ-MD-05) and partially reviewed the two remaining pivotal trials. The review was paused due to major deficiencies in the data that would have precluded issuing an approval. The sponsor chose to cancel their submission.

What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?

There is no expected impact for patients using SAP or in clinical trials. Viibryd is approved in Canada for a different indication.

Additional information

Proposed Brand Name:

Viibryd