Regulatory Decision Summary for Apo-desvenlafaxine

Desvenlafaxine succinate dissociates into its base form upon solubilisation. The metabolism is expected to be the same whether the succinate salt or base are administered. To support efficacy and safety of the product, the sponsor submitted the results of four bioavailability studies comparing Apo-Desvenlafaxine (desvenlafaxine base) extended-release tablets to the Canadian reference product, Pristiq (desvenlafaxine succinate) extended-release tablets. The results of the studies demonstrate that Apo-Desvenlafaxine 50 and 100 mg extended-release tablets met the recommended standard for comparative bioavailability with Pristiq 50 and 100 mg extended-release tablets, when administered under both fasting and high-fat fed conditions.

While no clinical efficacy studies were filed for this submission, the difference in the physicochemical form of the medicinal ingredient is not expected to result in a difference in safety or effectiveness. Thus, the demonstration of bioequivalence between this drug and Pristiq is considered to be sufficient as evidence of safety and efficacy, and a Notice of Compliance was issued.