When the government and big pharma join up for the betterment of the people, instances like this can happen.  Insys has lobbied repeatedly to keep natural marijuana/cannabis from becoming legalized while at the same time lobbying for their synthetic version Syndros to be approved by both DEA and FDA.  This begs the question of why??  Because much more money can be made with their version if the natural version is illegal?  Because the patents for the synthetic version would be deemed worthless if legalization did occur?  You decide how far is too far in this fight for America – from Big Pharma, Big Government and Big Deals.

DEA approves synthetic marijuana for big pharma company against legalization

A synthetic marijuana product could be available for commercialization after the DEA gave a newly approved drug a schedule II classification.  Syndros is a synthetic version of tetrahydrocannabinol (THC), the main psychoactive component in the plant.

On Thursday, Insys Therapeutics announced that the Drug Enforcement Administration (DEA) issued an interim final rule that would put Syndros, their synthetic marijuana drug, on Schedule II of the Controlled Substances Act (CSA).

Insys is looking forward to bringing this new drug product to chemotherapy patients to help alleviate their nausea and vomiting and AIDS patients with anorexia associated weight loss, respectively,” Dr. Santosh Vetticaden, interim CEO, said in the announcement.

We look forward to interacting with the FDA to finalize the labeling and subsequent launch of Syndros in the second half of 2017,” Vetticaden said.  [1]

Synthetic Marijuana Approved by DEA for Medicine While the Real Thing Remains Illegal

The announcement was made a few weeks ago in the Federal Register by the DEA that the drug Syndros, a liquid form of synthetic THC, will be now classified as a schedule 2 controlled substance, which means it can be legally prescribed by doctors. Meanwhile, organic marijuana continues to be listed right alongside heroin among Schedule 1 controlled substances. This category is reserved for drugs that have “no currently accepted medical use” and “a high potential for abuse.” Other drugs that have proven time and time again to hold medicinal value seem to be stuck in this category as well, although some things are changing.

“The DEA notes that FDA-approved products of oral solutions containing dronabinol [THC] have an approved medical use, whereas marijuana does not have an approved medical use and therefore remains in Schedule I,” the response continued.  There have been many reports of harmful reactions coming from the use of synthetic THC products.

Cannabis is a flower, and has many well-documented uses for healing. Both THC and CBD have already helped millions suffering from a wide rage of ailments. The only reason cannabis remains illegal is because it cannot be patented or regulated and therefore it cannot be capitalized on. [2]

Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] in Schedule II

DEA Schedules Insys Therapeutics’ Syndros (dronabinol oral solution) as Schedule II Drug

PRESS RELEASE:

Insys Therapeutics, Inc. (NASDAQ:INSY) today announced that the Drug Enforcement Agency (“DEA”) has issued an interim final rule that would result in Syndros™ (dronabinol oral solution) being placed in Schedule II of the Controlled Substances Act.

On July 1, 2016, the Food and Drug Administration (“FDA”) approved the New Drug Application for Syndros.

The use of dronabinol may cause psychiatric and cognitive effects and impair mental and/or physical abilities.
Patients with cardiac disorders may experience hypotension, hypertension, syncope or tachycardia.
May cause disulfiram-like reaction.
Weigh the potential risk versus benefits before prescribing Syndros to patients with a history of seizures, including those requiring anti-epileptic medication or other factors that lower the seizure threshold.
Assess risk for abuse or misuse in patients with a history of substance abuse or dependence, prior to prescribing Syndros and monitor for the development of associated behaviors or conditions.
Consider dose reduction or discontinuation, if worsening of symptoms while on treatment.
The safety and effectiveness of Syndros have not been established in pediatric patients.

Insys currently markets one product, SUBSYS® (fentanyl sublingual spray) but has received approval for the marketing of SYNDROS™ (dronabinol oral solution), a proprietary, orally administered liquid formulation of dronabinol that Insys believes has distinct advantages over the current formulation of dronabinol in soft gel capsule. Insys is committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy, and other disease areas with high unmet need.  [4]

Syndros Approval History

Syndros (dronabinol) is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol (THC) approved for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Development History and FDA Approval Process for Syndros

Date Article
Jul  5, 2016 Approval Insys Therapeutics Announces FDA Approval of Syndros (dronabinol) Oral Solution

[5]

Insys: Syndros Missteps And Even More Subsys Arrests

First, let’s start with Syndros. In terms of future operations for the company, Syndros is the main hope that the company has for being a cash generating entity in the future. It’s going to try and elbow its way into a $200m market that is currently occupied by THC drug Marinol. Syndros is, in essence, a liquid form of Marinol that the company argues is easier to take and dose because of its liquid form. Both the company and its investors were hoping to have Syndros labeled as a Schedule III drug by the FDA, but it was just announced last week that it would be a listed as a Schedule II drug. [6]

[7]

Pricing for Syndros 60 mL / 5mg/mL Oral Solution

  

[8]

A pharma company that spent $500,000 trying to keep pot illegal just got DEA approval for synthetic marijuana

Insys Therapeutics, a pharmaceutical company that was one of the chief financial backers of the opposition to marijuana legalization in Arizona last year, received preliminary approval from the Drug Enforcement Administration this week for Syndros, a synthetic marijuana drug.

Insys gave $500,000 last summer to Arizonans for Responsible Drug Policy, the group opposing marijuana legalization in Arizona. The donation amounted to roughly 10 percent of all money raised by the group in an ultimately successful campaign against legalization. Insys was the only pharmaceutical company known to be giving money to oppose legalization last year, according to a Washington Post analysis of campaign finance records.

“It appears they are trying to kill a non-pharmaceutical market for marijuana in order to line their own pockets,” a spokesman for Arizona’s marijuana legalization campaign said of Insys last year. [9]

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ADN Compilation: War On Drugs

SOURCES:

[1] RT

[2] Waking Times Media

[3]  Federal Register

[4]  Investors Insys

[5] Drugs.com

[6] Seeking Alpha

[7] Access Data FDA

[8]  GoodRx

[9]  Washington Post