Looking to placate the U.S. Food and Drug Administration and eventually win approval of its Oxycodone ER product, Intellipharmaceutics International (TSX:IPCI)(NASDAQ:IPCI) said Tuesday that it has begun its Category 2 and Category 3 human abuse liability studies necessary to support abuse-deterrent claims on the product's label.
Last year, the FDA, via a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the FDA Drug Safety and Risk Management Advisory Committee, shot down the Toronto-based company's new drug application for Oxycodone ER, saying it wants to see more clinical proof about the claims. Intellipharmaceutics developed Oxycodone ER using a formulation based on its proprietary technology coined nPODDDS™ (novel Point Of Divergence Drug Delivery System).
Management has been working with the FDA ever since receiving the Complete Response Letter and believes it is meeting all the regulator's demands to remain on track to re-submit the NDA by the end of the year.
The U.S. in in the midst of an opioid overdose epidemic. Oxycodone is a powerful painkiller and one of the most frequently abused prescription drugs in the country. In addition to education, the government is looking for ways to prevent abuse of the drug and remaining stringent on labeling laws.
Intellipharmaceutics submitted its NDA in February 2017 with support from a Category 1 abuse-deterrent study, which backed up its intravenous abuse deterrent claim. A critical pharmacokinetic study showed that its Oxycodone ER was equivalent to OxyContin and could be taken with or without food.
The meeting in July between the two committees determined that new studies related to abuse for the oral and intranasal routes of administration need to be conducted. Intellipharmaceutics has now kicked off the intranasal abuse study and the oral abuse studies are expected to start in the coming weeks.
The news of the studies was enough to energize the stock, which had sunk to an eight-year low this month. Shares of IPCI are up 12 cents, of 29.3%, at $0.53 as the closing bell approaches. In the States, shares of NASDAQ-listed IPCI are up 20.1% at 39.8 cents.
