FDA pointedly rejects Intellipharma’s opioid painkiller

The FDA has been very public in its stance that it will look to gain the upper hand in bringing the opioid epidemic under control, within its own remit. The nationwide crisis led to more than 50,000 deaths across the country, a rise of 540% over the course of the previous three years.

It is understandable that the agency was always going to be exceptionally careful when it came to approving any new opioid-based painkillers. Intellipharmaceutics has found this out to its own detriment, as its own product, known now as Oxycodone ER, was knocked back under the proviso that it return with further data.

Intellipharma, with the product, had created a novel means of dissuading would-be abusers of the drug by including blue dye with the ingredients. One of the ways that those suffering from opioid addiction look to abuse opioid painkiller is to ingest it nasally, and the company hopes that blue dye’s potential to signpost who had abused the drug would deter more from doing so.

Alongside this deterrent, the drug was also formulated to contain a nasal irritant – providing the drug with a double defence against those that would seek to abuse the drug in this way.

However, this was where the FDA pulled the drug up – it required more safety data on any potential toxicity of the blue dye and how this would impact those users who looked to misuse the drug intravenously.

The writing was already on the wall for a rejection of the drug, after the FDA’s advisory committee came in at 22-1 against approving the drug.

For Intellipharm’s part, the company reacted with an upbeat message that the rejection signposted the ways in which it should move forward.

"We are very encouraged by the FDA’s response as it clarifies our path forward for Oxycodone ER," said, Isa Odidi, CEO of Intellipharma. "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."

Odidi’s positive reaction, including that the additional studies had already been pencilled in, was enough to reassure investors; the company had suffered a severe drop after the FDA advisory committee’s reaction but on the official rejection, shares rose by 20%.