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Opioid Pain-killer Oxycodone ER rejected by FDA

August, 2018

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 known as Rexista. FDA sited Intellipharmaceutics complete 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 is in need of more evidence proving the treatment has characteristics that make it harder to abuse. An alternate proposed proprietary name for Oxycodone ER has also been requested. The company had been using the brand name Rexista, however is now calling it Oxycodone ER until further notice.

The FDA permitted Intellipharmaceutics one year to respond to the CRL and will allow extra time if requested. While lab tests were conducted to evaluate the abuse potential of its formulation, the company had not conducted any human studies to prove its product works as intended. Since Rexista is shown to be bioequivalent, and interchangeable with OxyContin in lab studies, the company believed conducting human studies prior to applying for approval was not imperative.

There has been a growth in the abuse of opioid painkillers in the US, which has led to stringent guidelines on new drugs coming onto the market. According to the Centers for Disease Control and Prevention, the opioid abuse led to more than 33,000 deaths in 2015. Drug deaths in the US in 2016 are estimated to be 59,000, the highest growth till date, according the New York Times. 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.

– Victor Mukherjee
Assistant Manager
Infoholic Research