While Cannabis remains as a Schedule I Drug, Syndros, a form of synthetic THC received a Schedule II


While Cannabis is classified as a Schedule I Drug.  Syndros (generic name: c-x dronabinol oral solution, a synthetic THC oral solution) manufactured by Insys Therapeutics, a Chandler, Arizona based pharmaceutical firm, receive the approval of Food and Drug Administration to be classified as Schedule II under the Controlled Substances Act, which would allow doctors to prescribe it.

 

Schedule II is the second-most restrictive drug classification category which is described as substances with a “high potential for abuse” but having some form of currently accepted medical use which includes Vicodin, cocaine, oxycodone, Adderall and Ritalin.

 

In 1985, FDA approved and regulated Marinol as a less-restrictive Schedule III substance. Marinol (dronabinol) is a man-made form of cannabis (also known as marijuana). Marinol is used to treat loss of appetite that causes weight loss in people with Acquired Immune Deficiency Syndrome (AIDS). Marinol is also used to treat severe nausea and vomiting caused by cancer chemotherapy. It is usually given after medicines to control nausea and vomiting have been tried without success.

 

According to GlobeNewswire, Syndros is a liquid formulation of the pharmaceutical cannabinoid dronabinol. Syndros is a new drug product indicated for use in chemotherapy patients to help alleviate their nausea and vomiting and AIDS patients with anorexia-associated weight loss, respectively,”

 

Saeed Motahari, President and Chief Executive Officer of INSYS, made a statement that “The launch of Syndros represents a pivotal milestone for us,”

 

“Syndros  is the second product entirely developed and commercialized by INSYS.  We are excited to make Syndros available to those patients in need and look forward to bringing additional novel therapeutic solutions to even more patients in the near future.”

 

Stephen Sherman, Senior Vice President, Regulatory Affairs of INSYS said, “Syndros  is the first and only FDA-approved liquid dronabinol.  It represents a viable alternative for the delivery of dronabinol and will fulfill a significant unmet need for both cancer patients undergoing chemotherapy who fail traditional antiemetics and AIDS patients who experience weight loss,”

 

According to The Cannabist, Health and Human Services officials said that liquid dronabinol has a higher potential for abuse than Marinol because the liquid formulation could be manipulated to produce extracts for vaping or edibles, according to the notice in the Federal Register.

Vetticaden told the Cannabist  last year that chemically synthesized drugs are highly reliable and thus could meet the rigorous testing demands and standards from the FDA. A synthetic approach could mitigate any potency issues that patients could encounter when buying products from dispensaries.

Insys, has expressed concerns about “natural cannabis” in regulatory filings to the U.S. Securities and Exchange Commission, and the legalization of marijuana:

“Moreover, our cannabinoid products may compete with non-synthetic cannabinoid drugs, including therapies such as GW Pharmaceuticals’ Sativex and Epidiolex, especially in many countries outside of the United States where non-synthetic cannabinoids are legal. In addition, literature has been published arguing the benefits of natural cannabis, or marijuana, over dronabinol, and there are a number of states that have already enacted laws legalizing medicinal and recreational marijuana. There is some support in the United States for further legalization of marijuana. We also cannot assess the extent to which patients utilize marijuana illegally to alleviate (Chemotherapy-Induced Nausea and Vomiting), instead of using prescribed therapies such as approved dronabinol products.”

Last fall, Insys contributed $500,000 to the campaign against marijuana legalization in Arizona. The $500,000 donation from Insys Therapeutics, amounts to more than one-third of all money raised by Arizonans for Responsible Drug Policy, the group opposing legalization.  According to campaign finance records maintained by ballotpedia.com, Insys is one of the largest single contributions to any anti-legalization campaign ever.  

 

Insys is facing multiple complaints, investigations and lawsuits related to its Subsys fentanyl spray (under-the-tongue spray intended for cancer patients that contains fentanyl, a highly addictive and regulated synthetic opioid).  It has been reported that Insys was accused of off-label marketing of the opioid painkiller and has faced allegations of providing kickbacks to doctors to prescribe it.

In a report by Reuters,  Insys has been accused of paying doctors sham speaker fees in exchange for writing prescriptions of Subsys and of misleading insurers into believing patients who were prescribed the opioid had cancer when they actually did not.

Brnovich also sued three Arizona doctors, Steve Fanto, Nikesh Seth and Sheldon Gingerich, whom the lawsuit said Insys paid on average $200,000 while they wrote prescriptions that generated over $33 million in sales of Subsys from March 2012 to April 2017.

Brnovich said in a statement that, “We need to put a stop to the unethical and greedy behavior in the pharmaceutical industry that is fueling the opioid crisis in our state,”.

Insys is in talks with the U.S. Department of Justice to resolve the federal probe. Investigations are held by attorneys general in Oregon, New Hampshire and Illinois, Insys previously agreed to pay a combined $8.95 million to resolve any investigations.

The lawsuit seeks an injunction, restitution for customers and the disgorgement of any illegally gained profits.

 

 

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04 Dec 2017


By Anne Kristina Aguila