Regulatory Decision Summary for Apo-Vilazodone

The purpose of this Abbreviated New Drug Submission (ANDS) was to obtain market authorization, pursuant to section C.08.004 of the Food and Drugs Regulations, for Apo-Vilazodone, filed by Apotex Inc., as the generic equivalent of the Canadian Reference Product (CRP) Viibryd, marketed by AbbVie Corporation (previously marketed by Allergan Inc.). This submission was filed for the symptomatic relief of Major Depressive Disorder (MDD).

The determination of applicable bioequivalence standards for vilazodone products requires special considerations due to the following reasons:

Vilazodone is considered to exhibit complicated pharmacokinetics due to an elimination half-life of greater than 24 hours. As food significantly increases bioavailability, vilazodone is recommended to be taken with food. A single-dose, crossover, comparative bioavailability study should be conducted in healthy subjects under fed conditions to establish bioequivalence between a proposed immediate-release vilazodone product and the CRP. The lowest vilazodone dose (10 mg) should be administered in the study, as a single high dose is associated with an increased occurrence of emesis.

The following standards should be met:

1. The 90% confidence interval of the relative mean AUC_0-72 of the test to the reference product should be within 80.0% - 125.0% inclusive.

2. The relative mean C_max of the test to the reference product should be within 80.0% - 125.0% inclusive.

The clinical component of the material provided to support this ANDS included one randomized, two-period, two-sequence, crossover, single oral dose (1 x 10 mg) comparative bioavailability study comparing the 10-mg strength of Apo-Vilazodone tablets to the 10-mg strength of Viibryd tablets in healthy male subjects under fed conditions (Study VI1143).

No critical concerns with regard to the design, conduct or, data from Study VI1143 were noted during review. The above detailed bioequivalence assessment criteria were met between Apo-Vilazodone and Viibryd 10 mg tablets, when administered under fed conditions.

Overall, Apo-Vilazodone was considered a pharmaceutical equivalent to the CRP based on review of quality data and information. Furthermore, comparative bioavailability data and labelling information were found to be acceptable. Therefore, a Notice of Compliance (NOC) was recommended.

For further details about Apo-Vilazodone, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.