Phase I open-label, laboratoty-blinded, randomized, crossover trial comparing Rexista oxycodone XR to Oxycontin under single dose fasting conditions
Phase of Trial: Phase I
Latest Information Update: 08 May 2018
At a glance
- Drugs Oxycodone (Primary)
- Indications Pain
- Focus Pharmacokinetics; Registrational
- 08 May 2018 According to an Intellipharmaceutics media release, the company expects to resubmit the NDA later in 2018.
- 25 Sep 2017 According to an Intellipharmaceutics International media release, the FDA recommended 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 and also to submit an alternate proposed proprietary name for Oxycodone ER. Intellipharmaceutics has been given one year to respond to the CRL, and can request additional time if necessary.
- 25 Sep 2017 According to an Intellipharmaceutics International media release, company has received a Complete Response Letter (CRL) from the U.S. FDA for its Oxycodone ER New Drug Application (NDA), wherein the FDA has determined that it cannot approve the application in its present form. The FDA has requested additional information related to the inclusion of the blue dye in the Oxycodone ER formulation, which is intended to deter abuse.