Intellipharmaceutics International Inc (NASDAQ:IPCI) shares tumbled 46% on Nasdaq on disappointing FDA related news.
Two US FDA advisory committees voted 22 to 1 in finding that its New Drug Application (NDA) for Rexista abuse-deterrent oxycodone hydrochloride extended release tablets should not be approved at this time.
The candidate is aimed as an abuse and alcohol-deterrent controlled-release oral formulation of oxycodone hydrochloride for the relief of pain.
Chief executive of Intellipharmaceutics, Dr. Isa Odidi, said: "While we are disappointed with the Committees’ overall vote, we will endeavor to remedy the concerns raised by completing the necessary human abuse potential studies in relation to the intranasal and oral routes of abuse.
"We will continue to work with the FDA in progressing this file over the next few weeks as we approach the September 25, 2017 PDUFA date.”
Shares shed 46.39% to $1.34.