- In a statement issued after yesterday's negative Ad Com vote on oxycodone candidate Rexista, Intellipharmaceutics (OTC:IPCI) says it will conduct a new human abuse potential (HAP) study to support an abuse-deterrent claim for the oral and intranasal routes. It plans to initiate the study in the coming weeks.
- More data will be required to support an abuse-deterrent claim for the intravenous route as well, but the company does not disclose its plans for addressing this.
- The FDA's action date is September 25.
- Previously: FDA Ad Com thumbs down on Intellipharmaceutics' oxycodone (July 26)
Intellipharmaceutics to conduct new HAP study to support abuse-deterrent claim for Rexista
Recommended For You
Related Stocks
Symbol | Last Price | % Chg |
---|---|---|
IPCI | - | - |
Intellipharmaceutics International Inc. |