Drug Development

Still in spotlight of a federal probe, Insys touts PhIII pain study as it preps an NDA

Still in the spotlight for federal investigations surrounding several cases of off-label marketing, Insys Therapeutics $INSY says it has come up with promising Phase III data for its most advanced spray formulation of an aging drug.

Insys CEO Dr. John Kapoor

Insys CEO Dr. John Kapoor

The drug is Buprenorphine Sublingual Spray, a new formulation for an addiction drug that is being repurposed to treat pain. Phoenix-based Insys says that they hit the primary endpoint in the study, testing three doses against a placebo for moderate to severe postoperative pain after a “bunionectomy.” The statement did not include any data, though. Now the company wants to start moving toward a new drug application.

Buprenorphine is another opioid used to help opioid addicts deal with symptoms of withdrawal and cravings.

“We are pleased with the results of this trial indicating that Buprenorphine Sublingual Spray could be a potentially useful drug for the treatment of moderate to severe pain and provide a valuable treatment option in a variety of clinical settings. We look forward to discussing these results with the FDA by the end of the year and subsequent next steps towards filing a New Drug Application,” said Insys CEO Dr. John Kapoor.

Kapoor got the top job after former CEO Michael Babich left the company last fall as company sales execs were being hauled into court to face charges of violating federal anti-kickback laws involving the sale of Subsys, another pain spray that Insys sells for cancer pain. Subsys includes the powerful opioid fentanyl, which was implicated in Prince’s death.

Just days ago a pair of ex-Insys sales execs pleaded not guilty to charges they were involved in a scheme to pay doctors speaking fees in exchange for prescribing Subsys. In another lurid case reported last February, former Insys rep Natalie Reed Perhacs pleaded guilty to kickback charges, disclosing that she was the inducement, hired by Insys after a top prescriber asked the company to bring her in.

The company has said that it is cooperating with federal investigators and has noted a settlement agreement with the Justice Department. Subsys earned $330 million last year, up from $95.8 million in 2013.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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