Insys Therapeutics Syndros Review – FDA Approved Cannabis Drug

There was big news in the cannabis industry today as the FDA approved Insys Therapeutics’ 2nd cannabis-based drug.

The drug is called Syndros. It’s a dronabinol drug designed to treat conditions related to AIDS and cancer. Two years ago, the FDA rejected Syndros. On July 5, 2016, the FDA officially approved the drug. After the announcement, Insys Therapeutics shares climbed 29%.

Syndros was specifically approved by the FDA to treat anorexia associated with weight loss in patients with AIDS. It was also approved to treat nausea and vomiting that occurs after cancer chemotherapy in patients who have not responded well to conventional nausea-management treatments.

The FDA rejected Insys Therapeutics in October 2014 after the company filed a new drug application to the regulatory body. In June 2015, Insys Therapeutics resubmitted their new drug application and it clearly worked.

The company’s stock (INSY) was down 62% on the year through Friday’s close after Insys reported poor first quarter sales of its flagship cancer-pain treatment product, Subsys. Those sales were below analysts’ expectations.

How Does Syndros Work?

Syndros is an oral liquid form of dronabinol, which is a drug used to treat nausea and vomiting caused by chemotherapy. It typically comes in the form of a capsule. It promotes appetite and reduces nausea by working as a cannabinoid.

It’s the first and only dronabinol solution approved by the FDA for oral use. It’s also a big deal because it comes in the form of an easy-to-swallow liquid. And, it doesn’t need to be refrigerated for 28 days.

Dosages can also be titrated for use in a clinical setting.

The drug specifically works by targeting the area of the brain that controls nausea, vomiting, and appetite.

Typical side effects of dronabinol include weakness, stomach pain, nausea, vomiting, memory loss, anxiety, and a “high” feeling. There are also more serious side effects, including seizures or an elevated heart-rate.

Doctors typically prescribe a low dose of dronabinol before increasing the dose as your body grows accustomed. However, overdoses are another risk of the drug. Typically, dronabinol is sold under the brand name Marinol, which is available in 2.5mg, 5mg, and 10mg capsules.

About Insys Therapeutics, Inc.

Insys Therapeutics is a specialty pharmaceutical company that, in the words of a press release announcing the news:

“develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve the quality of life of patients.”

The company is best-known for its proprietary sublingual spray technology and its pharmaceutical cannabinoid products. Subsys, the company’s flagship product, is a fentanyl sublingual spray that is currently on the market. Syndros, the dronabinol oral solution that was just approved, is the company’s second drug that has received FDA approval.