FDA Turns Down Insys Therapeutics’ Opioid Painkiller Over Safety Concerns

Rejection

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Phoenix, Arizona-based Insys Therapeutics for its buprenorphine sublingual spray for moderate-to-severe acute pain.

Company shares dropped almost 9 percent at the news on Friday, hitting $6.62. The product rejected by the FDA was an under-the-tongue spray formulation of buprenorphine, an opioid. Although the data submitted with the company’s drug application indicated all three proposed doses of the drug showed statistically significant pain relief compared to placebo, the FDA indicated concerns over safety.

On May 22, an FDA advisory committee voted not to recommend approval of the drug, so the final vote was consistent with the panel’s recommendation. At the time, Steve Sherman, Insys’ senior vice president of regulatory affairs, said in a statement, “We appreciate the panelists’ perspective and guidance. Believing that our sublingual delivery technology could contribute significantly to bring value to patients, we will continue to work with the FDA in the coming months to discuss the path forward for our buprenorphine product candidate and to build on the current body of evidence for its efficacy and safety.”

Reuters notes, “Insys has been embroiled in investigations related to its opioid cancer pain medication, Subsys. Last year, the company’s billionaire founder John Kapoor was charged with participating in a scheme to bribe doctors to prescribe Subsys and to defraud insurers into paying for it.”

In March, Jerrold Rosenberg, a physician in Rhode Island who took kickbacks from Insys, lost his medical license and was fired from his professorship at Brown University after pleading guilty to taking more than $188,000 in kickbacks in the form of speaker fees. He also made false patient records to defraud insurers into paying for Subsys. He was sentenced to more than four years in prison and ordered to pay $754,000 in restitution.

U.S. District Judge John J. McConnell Jr. said at the sentencing, “You in effect sold your medical license to a pharmaceutical company. That’s intolerable.”

Rosenberg was the fourth physician to be jailed over Insys bribes after a federal investigation that indicted John Kapoor and six other executives. Fortune wrote, “Federal prosecutors told the court Rosenberg ignored and bullied patients who resisted staying on the powerful pain-killing spray. At least one of Rosenberg’s patients suffered an overdose and was ‘near death’ as a result of his wrongdoing, the government said in court filings.”

Kapoor is scheduled for trial in 2019 for charges of racketeering and conspiracy. Both he and the other Insys executives have pleaded not guilty.

Insys is a specialty pharmaceutical company focused on cannabinoids and novel drug delivery systems. Subsys was the first and only breakthrough pain drug for patients with cancer offered as a sublingual spray. It is a unique formulation of the drug fentanyl. The company also has a cannabinoid product called Syndros on the market, which is used to treat loss of appetite (anorexia) in AIDS patients, and nausea and vomiting associated with chemotherapy.

Of the most recent rejection of buprenorphine, Sherman stated, “Given the attributes of our proprietary buprenorphine formulation for sublingual delivery, we continue to believe that this drug-device combination could bring value to the management of pain and will assess the next steps in the context of the company’s overall mission.”

 

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