Over the past 9 months Insys Therapeutics $INSY founder John Kapoor was charged with racketeering and bribery, company staffers pleaded guilty on a kickback scheme and the feds allied with company whistleblowers claiming that free dinners and entertainment were lavished on some doctors to encourage them to prescribe more of their fentanyl nasal spray.
And on Friday afternoon the FDA joined in the act, rejecting the company’s application for buprenorphine sublingual spray as a pain remedy, which the company says was due to unspecified safety concerns. The CRL highlighted the statistically significant efficacy data, Insys claimed in its statement.
That might come as a surprise to some of the 18 FDA experts who voted against the approval in the first place last May. Several noted some harsh side effects like nausea and vomiting, while others highlighted what they felt was a lousy response among patients who were studied.
“I think that if this were a standard schedule II opioid with the efficacy profile of this drug, we probably would not be here,”said Steven Meisel, system director of medication safety at Fairview Health Services, according to a report in Family Practice News. “We would not be here, because the efficacy [is] so weak compared to what is already out there. It just does not work for acute postoperative pain.”
The biotech’s shares dropped 7% on the news, indicating a lack of surprise among investors.
Insys has been undergoing a makeover in recent months which it says is meant to change the company culture under assault by the feds. Company execs say they’ll study the FDA’s complete response letter and decide on next steps.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 34,800+ biopharma pros who read Endpoints News by email every day.Free Subscription