Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

Robert Califf's FDA putting the brakes on Rexista?



More than one opioid company has gotten unexpected bad news since Cahill took over the FDA. Last we heard of an FDA opinion on Rexista was in May 2015, when IPCI reported the FDA letter that said no Phase 3 was required. Califf took over FDA a year later, in April 2016, after a significant public scolding from the U.S. Senate regarding the FDA's opioid approval process -AND- the FDA's cozy relationship with drug companies.

There have been many changes at the FDA since IPCI released any public info regarding current FDA guidance on Rexista. The company has now missed multiple self-imposed deadlines for Rexista NDA filing. While there are many possible explanations for this, one significant possibility is that the company does not feel confident with the application based on their most recent discussions with Robert Califf's "New" FDA.




https://www.ket.org/opioids/dr-robert-califf-on-the-fdas-action-plan-for-drug-addiction/

“There’s no question but that, over the last 10 to 15 years, there’s been too much opioid prescribing, and I think that almost everyone now is familiar with the history here,” Califf says.
...
Califf feels strongly about the responsibility of the pharmaceutical industry to reform its marketing practices. “There’s no question that the history of marketing opioids is a sinister part of American history that will be looked back upon very negatively,” he says.