ARTICLE | Clinical News

Intellipharmaceutics receives CRL from FDA for oxycodone ER

October 20, 2017 12:28 AM UTC

In September, Intellipharmaceutics International Inc. (TSX:IPCI; NASDAQ:IPCI) received a complete response letter from FDA for an NDA for oxycodone ER, a controlled-release formulation of oral oxycodone, to treat pain.

Intellipharmaceutics said the CRL recommended the company complete planned studies to evaluate the product's abuse-deterrent properties by oral and nasal routes and requested additional information about the product's blue dye ingredient, which the company said is intended to deter abuse. The agency also requested the company propose a different proprietary name for the product, previously known as Rexista...

BCIQ Target Profiles

Opioid receptor (OPR)