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Intellipharmaceutics’ opioid painkiller rejected by FDA

Intellipharmaceutics’ opioid painkiller Oxycodone ER has had approval withheld by the FDA, which has requested further information on its abuse-deterren...

Alex Brodie
|Sep 26|magazine5 min read

Intellipharmaceutics’ opioid painkiller Oxycodone ER has had approval withheld by the FDA, which has requested further information on its abuse-deterrent properties.

The company responded to the Complete Response Letter (CRL) from the FDA by stating the judgement was in line with its plans for the drug, formerly know as Rexista.

There has been a growth in the abuse of opioid painkillers in the US, which has lead to stringent guidelines on new drugs coming onto the market. 

Pharmaceutical companies must prove to the FDA that thorough research has been carried out to prove how use of the drug will not lead to abuse.

In line with this, the FDA requires Intellipharmaceutics 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. 

In a statement, Intellipharmaceutics CEO Dr Isa Odidi said: "We are very encouraged by the FDA's response as it clarifies our path forward for Oxycodone ER.

“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."

The opioid abuse problem in the US, according to the Centers for Disease Control and Prevention, claimed the lives of more than 33,000 people in 2015.

While in 2016, drug deaths in the US are expected to have risen to 59,000, the largest ever leap, according the New York Times, which compiled the figures.

The FDA has given Intellipharmaceutics one year to respond to the CRL and will allow extra time if requested. On top of this, the FDA has asked the company to create an alternative proprietary name for the drug.

Dr. Odidi concluded: "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. 

“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 company will be providing regular updates as we execute on our Oxycodone ER NDA resubmission plan."