In the complete response letter (CRL), the US Food and Drug Administration (FDA) requested further information on how the oxycodone hydrochloride extended-release tablets – in oral and nasal routes of administration – deters abuse, via Category 2 and Category 3 studies.
“We had already planned the additional Category 2 and Category 3 studies the FDA has requested and we do not expect they will impact our anticipated commercialisation timeline for Oxycodone ER,” said CEO Isa Odidi.
The CRL also requested further information regarding the blue dye in the formulation, designed to deter abuse, and asked the firm submit an alternate name for the product.
According to Intellipharmaceutics, the abuse-deterrent properties of Rexista are designed to discourage abuse or misuse via common routes of administration, including licking or crushing, inhalation, injection and ingestion after chewing.
“If approved, Rexista may be the only abuse-deterrent oxycodone product with properties that may provide early warning of drug abuse if the product is manipulated or abused,” said the firm.
The company said has one year to respond to the CRL, and plans to pursue the application in conjunction with the FDA.
“We will continue to work closely with the FDA to provide them with the additional information they requested, including data supporting the label claims related to Oxycodone ER’s abuse-deterrent properties,” said Odidi.
Rexista is an oxycodone hydrochloride extended release opiate analgesic designed to treat patients requiring long-term pain relief.
Intellipharmaceutics submitted its new drug application (NDA) for Rexista on February 2, 2017.
On June 26, the FDA’s Anaesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted against the approval of Rexista, 22 to 1.
A majority of members said Intellipharmaceutics had not demonstrated Rexista can deter abuse via intravenous injection.