The FDA has declined to approve Rexista, Intellipharmaceutics International’s new abuse-deterrent formulation of extended-release oxycodone, until additional studies are performed, the company announced.
The FDA issued a complete response letter (CRL) in relation to Intellipharmaceutics’ new drug application for Rexista. In its CRL, the FDA asked that Intellipharmaceutics complete the relevant category 2 and category 3 studies to assess the abuse-deterrent properties of oxycodone ER by the oral and nasal routes of administration.
The FDA also requested additional information related to the inclusion of blue dye in the oxycodone ER formulation, which the company said is intended to deter abuse. The FDA has determined that it cannot approve the new drug application (NDA) in its present form.
"We are very encouraged by the FDA's response as it clarifies our path forward for Oxycodone ER," said Dr. Isa Odidi, CEO of Intellipharmaceutics. "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 commercialization timeline for oxycodone ER."
Intellipharmaceutics has been given one year to respond to the CRL, and can request additional time if necessary. The FDA has also requested that Intellipharmaceutics submit an alternate proposed proprietary name for oxycodone ER.
"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,” Dr. Odidi said. “We believe our oxycodone ER product can play an important preventative role in the midst of a serious opioid abuse crisis particularly impacting North America."
The oxycodone ER product is an abuse deterrent oxycodone based on the company’s proprietary nPODDDS novel Point Of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), and Regabatin XR (pregabalin extended-release capsules).
Source: Intellipharmaceutics International Inc.; September 25, 2017.