Posted by Michael Wonder on 25 Sep 2017
Intellipharmaceutics receives complete response letter from the FDA for Rexista NDA
25 September 2017 - FDA response provides path toward commercialisation of Rexista.
Intellipharmaceutics today provided an update on its Rexista, henceforth referred to as Oxycodone Hydrochloride Extended-Release Tablets ("Oxycodone ER"), program.
The Company has received a complete response letter (CRL) from the United States FDA for its Oxycodone ER new drug application. In its CRL, the FDA provided certain recommendations and requests for information, including 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 the blue dye in the Oxycodone ER formulation, which is intended to deter abuse. The FDA has determined that it cannot approve the application in its present form.
