A new cannabis-based medicine that is used as a pain treatment for cancer patients has been approved in Peru.
Sativyl is a drug created by Verdemed that is intended to be as close to Sativex, another cannabis-based medicine that is used to treat cancer-related pain as well as offer relief for multiple sclerosis patients. Sativex recently was chosen to be used in an upcoming study on treating glioblastoma, an aggressive type of cancer that can occur in the brain or spinal cord. The medicine is used to relieve strong pain and is an effective, non-addictive substitute for opioids like morphine or oxycodone.
The drug could be effective at reducing the number of opioids prescribed to patients. Fatal drug overdoses rose 28.5 percent in a 12-month period from April 2020 to April 2021 according to data from the Center for Disease Control and Prevention’s National Center for Health Statistics. Synthetic opioids like fentanyl were the main drivers for the statistic, accounting for more than 63 percent of opioid-related deaths, along with methamphetamine. The data reported over 100,000 deaths for the first time.
Sativyl contains a 27mg/ml concentration of THC and 25mg/ml of CBD and works to control nausea caused by chemotherapy. The medicine is antiemetic which improves the patients appetite, which in turn gives their bodies more strength to continue chemotherapy. The medicine is sold by the flask and contains 10ml and 260mg of the concentration. It is produced in Canada by Verdemed in partnership with the Toronto Institute of Pharmaceutical Technology.
The Peruvian health license was approved less than one month after Verdemed received the approval from the Brazilian Sanitary Agency (ANVISA) to distribute full spectrum 50 mg/50 ml CBD, a medicine developed with the American-Colombian company Clever Leaves. Verdemed has also submitted documentation for Sativyl to ANVISA for review and approval.
“In January of next year, we’ll have Sativyl on the Peruvian market,” said José Bacellar, President and CEO of Verdemed. “We believe it will cost a third of Mevatyl (the Brazilian version of Sativex), coming up to a mere R$500 ($89.60).”
In 2018, the U.S. Food and Drug Administration approved Epidiolex, the first FDA approved drug that contains a substance that is derived from cannabis. The drug is used to treat seizures caused by two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. Epidiolex is also the first FDA approved drug that is used to treat Dravet syndrome. In 2020, the drug was approved to treat seizures associated with tuberous sclerosis complex (TSC).
Epidiolex was studied in three randomized clinical trials with 516 patients who suffer from either Lennox-Gastaut syndrome or Dravet syndrome. When taken along with other drugs, Epidiolex was shown to be effective in reducing seizures in patients compared to a placebo. The most common side effects of the drug are sleepiness, sedation and lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, fatigue, malaise and weakness, insomnia, sleep disorder and poor-quality sleep and infections.
In addition to Epidiolex, which is a naturally-derived cannabis drug, the FDA has approved three different synthetic-cannabis related drug products: Marinol, Syndros and Cesamet. Marinol and Syndros are both used to treat loss of appetite that causes wasting syndrom in patients with AIDS. It is also used to treat severe nausea and vomiting in cancer patients undergoing chemotherapy. Cesamet is used to control nausea and vomiting in patients going through chemotherapy as well. Marinol and Syndros contain the active ingredient dronabinol, while Cesamet contains nabilone.
All of the cannabis-derived medicines, whether natural or man-made, are only available through licensed physicians and are usually given when all other options have been exhausted.