Synthetic, pharmaceutically manufactured versions of the cannabinoid tetrahydrocannabinol (THC) have never taken off, although it’s been marketed for decades. Now, Insys Therapeutics ($INSY) has gained an FDA approval for the latest iteration--a liquid formulation of dronabinol, a pharmaceutical version of THC.
Known as Syndros, it’s approved to treat anorexia associated with weight loss in patients with AIDS, as well as nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Insys expects to launch it next half.
“Syndros is the first and only FDA approved dronabinol solution for oral use. It is a liquid that is easy-to-swallow and allows for the dosage to be titrated to clinical effect. Once Syndros has been opened, it does not need to be refrigerated for 28 days,” noted Insys Chairman, President and CEO Dr. John Kapoor in a statement. “We believe that these product features coupled with patient support services will prove to be important differentiators for patients and prescribers and will be key drivers of a successful market launch and sustained growth.”
Insys aims to address the small but long-standing market created by the pill formulation of dronabinol. The branded version of this is marketed as Marinol by AbbVie ($ABBV). The liquid version is expected to be faster-acting and easier for nauseous patients to keep down than the current soft gel capsule version. It’s also expected to require a lower dose than Marinol, or its handful of generic counterparts.
The liquid dronobinol will be the second marketed product from Insys after its Subsys fentanyl sublingual spray to treat cancer pain. The company expects to specifically target existing Marinol prescribers with its current sales force. It’s aiming to reach the physicians who account for roughly 80% of the Marinol market. An estimated 9,500 prescribers account for 70% of dronabinol prescriptions.
The approval came after the agency delayed the Syndros PDUFA date to July 1 from April 1. The extension was in response to the company’s voluntary decision to submit Syndros under the Controlled Substances Act. This requires classifying the drug as to how restricted its access will be.
Insys is still waiting for the U.S. Drug Enforcement Administration to schedule Syndros, but the company has previously said it expects for it to be Schedule II. This designation is for substances deemed highly addictive and potentially dangerous but having some medical value.
If the drug launches as Schedule III, which is deemed less addictive than Schedule II, Insys anticipates peak annual sales of $200 million to $300 million. But a Schedule II designation would trim that by an estimated 20% to 25%.
"We believe that Syndros will be an important new treatment option for patients suffering from the devastating effects of chemotherapy induced nausea and vomiting, as well as those fighting anorexia associated with weight loss in AIDS,” added Dapoor.
Insys was up almost 15% in early trading on the news to a market cap of about $1.1 billion. But its share price remains off by almost half for the year. Late last year, the company's CEO stepped down amidst an investigation into off-label promotion for Subsys.
- here is the release